MEDTRONIC ATS MEDICAL, INC.: 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

Is my product affected?

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.

• UPC 00763000114626

Check against the official notice below — it lists the full affected range.

What happened

Medtronic ATS Medical, Inc. is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe, Model Number 60SF3, due to a potential defect in the seals of the sterile barrier pouch used to package these single-use, disposable medical devices. The affected devices were distributed worldwide, including throughout the United States and in Belgium, Czech Republic, Germany, and Korea, with specific serial numbers identified in the recall notice.

The recall record does not specify what consumers or healthcare facilities should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices Distribution: Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea. Quantity: 57 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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