Reported Dec 2, 2020 · Terminated
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use,…
Medtronic Ats Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDTRONIC ATS MEDICAL, INC. · 3800 Annapolis Ln N · Plymouth, MN · 55447-5439
Is this the product you have?
- 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.
- Lot codes and dates
Model Number 60SF7GTIN 00763000114633
- Serial Numbers
177200001772000117720002177200111772001217720013177200141772001517720016177200171772001817720019177200201772002120620000
- Amount recalled
- 15 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
This product could cause temporary or reversible health problems — stop using it.
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