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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65553

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

Open FDA event record

Event summary

Timeline bucket
June 17, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
LeMaitre Vascular, Inc.

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

17 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 17

AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1754-2013
Recall number
Z-1754-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 2 of 17

AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1755-2013
Recall number
Z-1755-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 3 of 17

Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1756-2013
Recall number
Z-1756-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 4 of 17

AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1757-2013
Recall number
Z-1757-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 5 of 17

AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1758-2013
Recall number
Z-1758-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 6 of 17

AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1759-2013
Recall number
Z-1759-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 7 of 17

AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1760-2013
Recall number
Z-1760-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 8 of 17

AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1761-2013
Recall number
Z-1761-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 9 of 17

AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1762-2013
Recall number
Z-1762-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 10 of 17

AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1763-2013
Recall number
Z-1763-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
2 untis

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 11 of 17

AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1764-2013
Recall number
Z-1764-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 12 of 17

AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1765-2013
Recall number
Z-1765-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 13 of 17

AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1766-2013
Recall number
Z-1766-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 14 of 17

AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1767-2013
Recall number
Z-1767-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 15 of 17

AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1768-2013
Recall number
Z-1768-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 16 of 17

AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1769-2013
Recall number
Z-1769-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

device · product 17 of 17

AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1770-2013
Recall number
Z-1770-2013
Initiated
June 17, 2013
Classification
Class I
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blood blushing/leaking from the surface of the graft after implantation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Code information

Lot number/Expiration Date 56890A 2015-04

Distribution pattern

Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

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