MEDTRONIC ATS MEDICAL, INC. recalls Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, dispo

Recalled December 2, 2020 · FDA recall Z-0495-2021 · MEDTRONIC ATS MEDICAL

Hazard

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

Units

15 units

Sold at

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

Description

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

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.

Manufacturer(s)

MEDTRONIC ATS MEDICAL, INC.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →