FDA-Device2020-12-02Class II
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 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.
MEDTRONIC ATS MEDICAL, INC.
Hazard
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
Affected count
57 units
Manufactured in
3800 Annapolis Ln N, N/A, Plymouth, MN, United States
Products
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0494-2021Don't want to check this manually?
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