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.
Reported: December 2, 2020 Initiated: October 12, 2020 #Z-0493-2021
Product Description
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.
Reason for Recall
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Details
- Recalling Firm
- MEDTRONIC ATS MEDICAL, INC.
- Units Affected
- 37 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by MEDTRONIC ATS MEDICAL, INC.. Units affected: 37 units.
Why was this product recalled? ▼
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2020. Severity: Moderate. Recall number: Z-0493-2021.
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