Recall record at a glance
| Official record | Z-0496-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | MEDTRONIC ATS MEDICAL, Inc. |
| Report date | Dec 2, 2020 |
| Recall initiation date | Oct 12, 2020 |
| Quantity | 3 units |
| Location | Plymouth, MN, United States |
Official product description
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 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.
Why the product was recalled
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Distribution information
Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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