Cardioblate CryoFlex — Class II medical device recall Z-0494-2021
Terminated recall by MEDTRONIC ATS MEDICAL, INC., reported 2020-12-02, distributed nationwide. There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables
| Recall number | Z-0494-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDTRONIC ATS MEDICAL, INC., Plymouth, MN, United States |
| Recall initiated | 2020-10-12 |
| Classified | 2020-11-25 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2024-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CZ, DE, KR |
| Quantity | 57 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00763000114626 |
| Serial numbers | 17420000, 17420001, 17420002, 17420003, 17420004, 17420005, 17420006, 17420007, 17420008, 17420009, 17420010, 17420013, 17420014, 17420015, 17420016, 17420017, 17420018, 17420019, 17420020, 17420022, 17420023, 17420024, 17420025, 17420026, 17420027 and 32 more |
| Model numbers | 60SF3 |
Product
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.
Reason for recall
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0494-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.