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 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.


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 60CM1, GTIN 00763000114640, Serial Numbers: 18920000, 18920001, 18920002
View official government recall

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