Exact FDA event identifier

Event 86666

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

Event summary

Timeline bucket: October 12, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: MEDTRONIC ATS MEDICAL, 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

4 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 4

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Z-0493-2021

Recall number: Z-0493-2021
Initiated: October 12, 2020
Classification: Class II
Status: Terminated
Recalling firm: MEDTRONIC ATS MEDICAL, INC.
Quantity: 37 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

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

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Code information

Model Number 60SF2, GTIN 00763000114619, Serial Numbers: 18920030, 18920031, 18920032, 18920033, 18920034, 18920035, 18920036, 18920037, 18920038, 18920039, 18920040, 18920041, 18920043, 18920045, 18920046, 18920047, 18920048, 18920049, 18920050, 18920051, 18920052, 18920053, 18920054, 18920055, 20420030, 20420031, 20420032, 20420033, 20420038, 20420039, 20420040, 20420041, 20420046, 20420047, 20420049, 20420050, 20420051

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

device · product 2 of 4

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Z-0494-2021

Recall number: Z-0494-2021
Initiated: October 12, 2020
Classification: Class II
Status: Terminated
Recalling firm: MEDTRONIC ATS MEDICAL, INC.
Quantity: 57 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

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

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Code information

Model Number 60SF3, GTIN 00763000114626 Serial Numbers: 17420000, 17420001, 17420002, 17420003, 17420004, 17420005, 17420006, 17420007, 17420008, 17420009, 17420010, 17420013, 17420014, 17420015, 17420016, 17420017, 17420018, 17420019, 17420020, 17420022, 17420023, 17420024, 17420025, 17420026, 17420027, 17420028, 17420029, 18420000, 18420001, 18420002, 18420003, 18420004, 18420015, 18420016, 18420021, 18420022, 18420023, 18420024, 18420025, 18420026, 18420027, 19820016, 19820017, 19820018, 19820019, 19820020, 19820021, 19820022, 19820023, 19820024, 21020005, 22320038, 22320040, 22320041, 22320042, 22320043, 22320044

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

device · product 3 of 4

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Z-0495-2021

Recall number: Z-0495-2021
Initiated: October 12, 2020
Classification: Class II
Status: Terminated
Recalling firm: MEDTRONIC ATS MEDICAL, INC.
Quantity: 15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

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

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Code information

Model Number 60SF7, GTIN 00763000114633, Serial Numbers: 17720000, 17720001, 17720002, 17720011, 17720012, 17720013, 17720014, 17720015, 17720016, 17720017, 17720018, 17720019, 17720020, 17720021, 20620000

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

device · product 4 of 4

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Z-0496-2021

Recall number: Z-0496-2021
Initiated: October 12, 2020
Classification: Class II
Status: Terminated
Recalling firm: MEDTRONIC ATS MEDICAL, INC.
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

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

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Code information

Model Number 60CM1, GTIN 00763000114640, Serial Numbers: 18920000, 18920001, 18920002

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.