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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94240

48 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 21, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

48 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter

Z-1638-2024
Recall number
Z-1638-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
16797 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187684, Batch Numbers: 60425778, 60427745, 60438674, 60456279, 60465785, 60476456, 60427256, 60430877, 60440972, 60465783, 60472599, 60479447, 60427594, 60430933, 60449235, 60465784, 60474047, 60479448, 60474048, 60522588

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 2 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter

Z-1639-2024
Recall number
Z-1639-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
297479 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187691, Batch Numbers: 60423767, 60436637, 60449962, 60467488, 60481586, 60500723, 60423768, 60438203, 60449964, 60467118, 60481588, 60500724, 60423772, 60438204, 60449961, 60467489, 60482882, 60500725, 60425130, 60436635, 60453707, 60469085, 60482883, 60500726, 60425128, 60438654, 60457132, 60472566, 60482881, 60500728, 60425129, 60438652, 60456262, 60473138, 60483867, 60500727, 60425763, 60438653, 60461405, 60474065, 60483868, 60504878, 60425764, 60440739, 60461406, 60474066, 60483869, 60504879, 60425765, 60440950, 60461408, 60474067, 60483870, 60504880, 60427255, 60442609, 60461407, 60474068, 60483872, 60512235, 60427593, 60442607, 60463410, 60474069, 60483858, 60519446, 60427715, 60443038, 60463411, 60474070, 60483871, 60519447, 60427716, 60443909, 60463956, 60474071, 60485566, 60519448, 60427717, 60445389, 60463957, 60474013, 60486069, 60519445, 60427720, 60445901, 60463958, 60474015, 60486070, 60521830, 60427718, 60445902, 60463407, 60476442, 60487589, 60521831, 60430441, 60445910, 60463409, 60476145, 60487590, 60522905, 60430885, 60445913, 60463408, 60476146, 60487591, 60522903, 60430914, 60445899, 60463959, 60476147, 60487592, 60522904, 60432697, 60445912, 60463960, 60476148, 60487593, 60525055, 60432698, 60445900, 60463961, 60476149, 60488284, 60525056, 60432699, 60445909, 60464366, 60479441, 60488286, 60525058, 60432700, 60445911, 60464367, 60479442, 60488287, 60523275, 60432714, 60445903, 60465466, 60479443, 60488285, 60525078, 60433871, 60449229, 60464440, 60479444, 60492194, 60526117, 60433882, 60449230, 60464441, 60479445, 60492195, 60526118, 60437043, 60449236, 60467115, 60479446, 60492196, 60526119, 60437781, 60449963, 60467117, 60481587, 60492197, 60526189, 60437780, 60449958, 60467119, 60481583, 60493940, 60526190, 60438205, 60449959, 60467116, 60481584, 60493941, 60526191, 60438502, 60449960, 60467490, 60481585, 60495538, 60526120, 60495539, 60526121

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 3 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter

Z-1640-2024
Recall number
Z-1640-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729366478, Batch Numbers: 60466921

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 4 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter

Z-1641-2024
Recall number
Z-1641-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
15079 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187707, Batch Numbers: 60429295, 60452070, 60467044, 60475390, 60491910, 60525061, 60430929, 60459221, 60472581, 60483688, 60498233, 60530044, 60512378, 60536198,

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 5 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter

Z-1642-2024
Recall number
Z-1642-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
290 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187714, Batch Numbers: 60493978, 60530035

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 6 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter

Z-1643-2024
Recall number
Z-1643-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
385 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729248705, Batch Numbers: 60448979, 60500188, 60535893

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 7 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter

Z-1644-2024
Recall number
Z-1644-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
1465 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187721, Batch Numbers: 60448983, 60461410, 60476253, 60486049, 60517315

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 8 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter

Z-1645-2024
Recall number
Z-1645-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
120 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187776, Batch Numbers: 60447174

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 9 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter

Z-1646-2024
Recall number
Z-1646-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
230 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249030, Batch Numbers: 60504831, 60515598, 60533629

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 10 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter

Z-1647-2024
Recall number
Z-1647-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
3127 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729168928, Batch Numbers: 60447160, 60463413, 60472609, 60481602, 60493975, 60517338, 60511235, 60533588

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 11 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter

Z-1648-2024
Recall number
Z-1648-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
5510 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187790, Batch Numbers: 60443926, 60463398, 60472605, 60473187, 60498234, 60524982, 60513387, 60533587, 60535875

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 12 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter

Z-1649-2024
Recall number
Z-1649-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
25617 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187806, Batch Numbers: 60432320, 60447145, 60468840, 60491659, 60515603, 60523996, 60438675, 60459197, 60475371, 60495554, 60522591, 60533644, 60440974, 60467093, 60483661, 60504885, 60522595, 60536197

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 13 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter

Z-1650-2024
Recall number
Z-1650-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
2366 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249191, Batch Numbers: 60447151, 60456265, 60472610, 60486304, 60522592, 60531432

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 14 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter

Z-1651-2024
Recall number
Z-1651-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
1170 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249214, Batch Numbers: 60448987, 60467091, 60476275, 60486323, 60535894

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 15 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter

Z-1652-2024
Recall number
Z-1652-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
8725 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729376675, Batch Numbers: 60433909, 60459200, 60467047, 60486322, 60504866, 60533642, 60447140, 60463976, 60474043, 60504859, 60517330

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 16 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter

Z-1653-2024
Recall number
Z-1653-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
263522 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187813, Batch Numbers: 60423725, 60438648, 60449984, 60474078, 60488293, 60507284, 60427729, 60438649, 60453725, 60474079, 60490173, 60507287, 60427730, 60440943, 60453726, 60474080, 60490174, 60507479, 60427731, 60440944, 60461414, 60475372, 60490175, 60507660, 60427732, 60440945, 60461429, 60475376, 60490176, 60507661, 60427733, 60440946, 60536188, 60475377, 60490177, 60507662, 60427734, 60440947, 60463596, 60475378, 60490178, 60507663, 60430886, 60443002, 60463598, 60475379, 60490179, 60511641, 60430922, 60443027, 60463962, 60476443, 60491458, 60511642, 60430923, 60443028, 60463972, 60476444, 60491465, 60511643, 60430925, 60443029, 60463973, 60477294, 60491466, 60511644, 60432701, 60443030, 60464490, 60477295, 60491467, 60515578, 60432702, 60443031, 60464491, 60477296, 60493944, 60515579, 60432716, 60443897, 60467016, 60477297, 60495540, 60515580, 60432719, 60443898, 60467017, 60479452, 60495541, 60517602, 60433872, 60443899, 60467018, 60479453, 60495542, 60517603, 60433875, 60443900, 60467019, 60479454, 60495543, 60517604, 60433885, 60443901, 60467020, 60479455, 60495544, 60517607, 60433886, 60443902, 60469093, 60481591, 60495545, 60522510

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 17 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter

Z-1654-2024
Recall number
Z-1654-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
2990 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729007531, Batch Numbers: 60438212, 60449780, 60491491, 60491959, 60521828

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 18 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter

Z-1655-2024
Recall number
Z-1655-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
116091 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187820, Batch Numbers: 60427721, 60437784, 60456288, 60473154, 60481598, 60500737, 60427722, 60443032, 60461431, 60473157, 60481599, 60505121, 60427723, 60443033, 60462014, 60474023, 60481600, 60512236, 60427724, 60443034, 60463401, 60474083, 60481601, 60512384, 60427725, 60443035, 60463402, 60474084, 60488294, 60512385, 60427726, 60443036, 60463600, 60474085, 60488295, 60521834, 60430878, 60443903, 60463954, 60476445, 60488296, 60521835, 60430926, 60443904, 60463955, 60477256, 60488297, 60521836, 60430927, 60443905, 60463967, 60479456, 60488298, 60522587, 60430928, 60443906, 60463974, 60479457, 60492673, 60522901, 60432308, 60443907, 60464492, 60479458, 60492674, 60522902, 60432309, 60446725, 60470527, 60479459, 60492675, 60525059, 60432310, 60448203, 60470528, 60479460, 60492676, 60525077, 60434240, 60448204, 60470530, 60479461, 60492677, 60527362, 60434481, 60448205, 60470531, 60481596, 60498229, 60527363, 60436641, 60452064, 60472576, 60481597, 60498230, 60533639, 60538215

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 19 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter

Z-1656-2024
Recall number
Z-1656-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
5435 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729192817, Batch Numbers: 60430691, 60447156, 60463406, 60488300, 60493468, 60537513

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 20 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter

Z-1657-2024
Recall number
Z-1657-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
330 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729007562, Batch Numbers: 60449785, 60491507, 60537491

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 21 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter

Z-1658-2024
Recall number
Z-1658-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
4715 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187837, Batch Numbers: 60443928, 60457123, 60464496, 60473188, 60504888, 60522597, 60477305, 60517337, 60533589

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 22 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter

Z-1659-2024
Recall number
Z-1659-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
15 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729007579, Batch Numbers: 60533582

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 23 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter

Z-1660-2024
Recall number
Z-1660-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
1065 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729007593, Batch Numbers: 60444872, 60451459, 60451968, 60511220

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 24 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter

Z-1661-2024
Recall number
Z-1661-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
4270 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729886082, Batch Numbers: 60447162, 60461412, 60474054, 60486303, 60495529, 60511248, 60511234, 60531435

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 25 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter

Z-1662-2024
Recall number
Z-1662-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
1669 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187851, Batch Numbers: 60447163, 60464498, 60485991, 60515607, 60517314, 60533583

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 26 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter

Z-1663-2024
Recall number
Z-1663-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729886129, Batch Numbers: 60535890

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 27 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter

Z-1664-2024
Recall number
Z-1664-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
10 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729886143, Batch Numbers: 60500256, 60536210

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 28 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter

Z-1665-2024
Recall number
Z-1665-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
363 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729521501, Batch Numbers: 60443927, 60495422

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 29 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter

Z-1666-2024
Recall number
Z-1666-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
46860 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187868, Batch Numbers: 60427727, 60456253, 60462030, 60476271, 60500758, 60530055, 60436627, 60460188, 60474027, 60477271, 60502673, 60537578, 60438198, 60461419, 60475349, 60486289, 60515228

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 30 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter

Z-1667-2024
Recall number
Z-1667-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
847 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729521518, Batch Numbers: 60451436, 60470651, 60490172, 60495478

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 31 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter

Z-1668-2024
Recall number
Z-1668-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
86898 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187875, Batch Numbers: 60422723, 60442593, 60463980, 60477215, 60490182, 60504886, 60422730, 60442594, 60463981, 60477318, 60496717, 60509543, 60423803, 60449237, 60465461, 60478140, 60498231, 60532101, 60423804, 60452059, 60470647, 60480055, 60500299, 60532102, 60438197, 60453695, 60472578, 60486055, 60500755, 60536194, 60438657, 60456291, 60476246, 60486317, 60500756, 60536195, 60438658, 60459250, 60476454, 60490180, 60500757, 60536196, 60440954, 60463066, 60477214, 60490181, 60502671

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 32 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter

Z-1669-2024
Recall number
Z-1669-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
15270 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187882, Batch Numbers: 60447157, 60462032, 60480056, 60493500, 60524948, 60447158, 60477290, 60480062, 60504860, 60533592

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 33 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter

Z-1670-2024
Recall number
Z-1670-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
105 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249382, Batch Numbers: 60480059

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 34 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter

Z-1671-2024
Recall number
Z-1671-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
2314 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249399, Batch Numbers: 60429298, 60451469, 60459243, 60481409, 60535930, 60434211, 60454956, 60463953, 60490141, 60535931, 60436616, 60459198, 60463979, 60517312, 60536204

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 35 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter

Z-1672-2024
Recall number
Z-1672-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
23529 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249412, Batch Numbers: 60437054, 60447182, 60463964, 60477273, 60488498, 60495556, 60437063, 60447183, 60465472, 60481568, 60488499, 60497690, 60437064, 60448980, 60465473, 60483603, 60488500, 60507240, 60438200, 60448981, 60465481, 60483604, 60490167, 60507657, 60438201, 60448982, 60465482, 60483634, 60490169, 60507658, 60438202, 60454958, 60465483, 60483635, 60490170, 60507659, 60445390, 60460144, 60474107, 60483638, 60490171, 60517310, 60447181, 60463963, 60474501, 60488390, 60491660, 60517311, 60488497, 60491661, 60530050, 60495555, 60538219

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 36 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter

Z-1673-2024
Recall number
Z-1673-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
1950 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249429, Batch Numbers: 60447165, 60490140, 60490183

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 37 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter

Z-1674-2024
Recall number
Z-1674-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
1322 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249498, Batch Numbers: 60442598, 60442599, 60448185, 60459199, 60488391, 60490138, 60451431, 60467097, 60490137, 60490168

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 38 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter

Z-1675-2024
Recall number
Z-1675-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
8575 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729249504, Batch Numbers: 60442603, 60448206, 60463966, 60481407, 60491911, 60492607, 60443053, 60457140, 60467045, 60485945, 60492554, 60492608, 60443054, 60457142, 60467046, 60488392, 60492605, 60448186, 60463965, 60481406, 60488393, 60492606

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 39 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter

Z-1676-2024
Recall number
Z-1676-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
440 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729812166, Batch Numbers: 60468842

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 40 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter

Z-1677-2024
Recall number
Z-1677-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
1015 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729812180, Batch Numbers: 60436618, 60477262, 60477325, 60535891, 60540487

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 41 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter

Z-1678-2024
Recall number
Z-1678-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
615 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729812203, Batch Numbers: 60447147, 60467099, 60492626

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 42 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter

Z-1679-2024
Recall number
Z-1679-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
95 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729812227, Batch Numbers: 60442614

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 43 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter

Z-1680-2024
Recall number
Z-1680-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
11109 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187929, Batch Numbers: 60425143, 60448984, 60474111, 60482880, 60525062, 60427595, 60448985, 60477260, 60502674, 60530043, 60429297, 60463971, 60479435, 60511249, 60536205

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 44 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter

Z-1681-2024
Recall number
Z-1681-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
9271 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729168874, Batch Numbers: 60430930, 60447169, 60462004, 60475385, 60515237, 60525060, 60447168, 60461420, 60474038, 60486305, 60522598, 60531431, 60540176

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 45 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter

Z-1682-2024
Recall number
Z-1682-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
4942 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729007692, Batch Numbers: 60443056, 60452071, 60464497, 60467054, 60475380, 60511251, 60498235, 60533590

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 46 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter

Z-1683-2024
Recall number
Z-1683-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
37252 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187936, Batch Numbers: 60438199, 60453733, 60472577, 60486300, 60500754, 60513563, 60438660, 60459203, 60473158, 60491662, 60507655, 60529457, 60440956, 60465786, 60477280, 60495526, 60507656, 60533641, 60445923, 60465788, 60477281, 60495527, 60511179, 60538216, 60448986, 60467041, 60477282, 60498225, 60511181, 60538217, 60449233, 60467087, 60486299, 60498226, 60512377

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 47 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter

Z-1684-2024
Recall number
Z-1684-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
8715 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187943, Batch Numbers: 60434245, 60454961, 60477302, 60510080, 60536207, 60447166, 60474029, 60483669, 60533638, 60540481

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

device · product 48 of 48

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter

Z-1685-2024
Recall number
Z-1685-2024
Initiated
March 21, 2024
Classification
Class I
Status
Ongoing
Quantity
8579 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Code information

UDI/DI 08714729187844, Batch Numbers: 60432312, 60448988, 60448989, 60459201, 60464505, 60465484, 60467102, 60467103, 60467104, 60467105, 60467106, 60467107, 60467121, 60469088, 60477210, 60477211, 60477213, 60479437, 60479438, 60481581, 60481582

Distribution pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Field note

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