medical Class II Updated 2020-12-02

MEDTRONIC ATS MEDICAL, INC. recalls Cardioblate CryoFlex, Surgical Ablation Probe, Model Number

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

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

View official government recall

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