MEDTRONIC ATS MEDICAL, INC.: Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed fo

Is my product affected?

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 abla

• UPC 00763000114619

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

What happened

Medtronic ATS Medical is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe, Model Number 60SF2, a single-use disposable cryoprobe used in cardiac surgery. The recall was issued due to a potential defect in the seals of the sterile barrier pouches used to package these devices. The affected devices were distributed worldwide, including throughout the United States and in Belgium, Czech Republic, Germany, and Korea, with specific serial numbers ranging from 18920030 to 20420051.

The recall record does not specify a remedy or action for affected consumers.

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: 37 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

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

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