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MEDTRONIC ATS MEDICAL, INC. recalls Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a s
Recalled December 2, 2020 · FDA recall Z-0493-2021 · 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
37 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 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 ablation segment.
Manufacturer(s)
MEDTRONIC ATS MEDICAL, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →