Reported Dec 2, 2020 · Terminated
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a…
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 60SF2, PROBE 60SF2
- CRYOFLEX 10CM 26L - Product Usageis 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 60SF2GTIN 00763000114619
- Serial Numbers
18920030189200311892003218920033189200341892003518920036189200371892003818920039189200401892004118920043189200451892004618920047189200481892004918920050189200511892005218920053189200541892005520420030204200312042003220420033204200382042003920420040204200412042004620420047204200492042005020420051
- Amount recalled
- 37 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.