MEDTRONIC ATS MEDICAL, INC.: 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 C

Is my product affected?

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.

• UPC 00763000114633

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

What happened

Medtronic ATS Medical, Inc. is recalling 15 units of the Cardioblate CryoFlex Surgical Ablation Probe, Model Number 60SF7, a single-use disposable cryoprobe. The recall was issued due to a potential defect in the seals of the sterile barrier pouch used to package these devices. The affected devices were distributed nationwide in the United States as well as in Belgium, Czech Republic, Germany, and Korea, with specific serial numbers ranging from 17720000 to 20620000.

The recall affects devices with Model Number 60SF7 and GTIN 00763000114633. The source document does not specify what actions affected consumers or healthcare facilities should take regarding 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: 15 units Lot/code info: Model Number 60SF7, GTIN 00763000114633, Serial Numbers: 17720000, 17720001, 17720002, 17720011, 17720012, 17720013, 17720014, 17720015, 17720016, 17720017, 17720018, 17720019, 17720020, 17720021, 20620000

Source

Official record: FDA (Device enforcement) ↗

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

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All FDA (Device enforcement) recalls