Cardioblate CryoFlex Surgical Ablation Console — Class II medical device recall Z-0273-2022
Ongoing recall by Medtronic Perfusion Systems, reported 2021-12-01, distributed in IL, KS, UT. There is potential for intermittent electrical connectivity between the console and probe.
| Recall number | Z-0273-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2021-09-27 |
| Classified | 2021-11-19 |
| Reported by FDA | 2021-12-01 |
| Distributed | IL, KS, UT |
| Countries outside the US | AU, KR |
| Quantity | 7 devices |
| UPC / GTIN / UDI-DI | 00613994867315, 00613994981516, 00643169183834, 00763000014988 |
| Serial numbers | 10047, 10048, 10050, 10051, 1689, CSC-591, CSC055, RCSC-201 |
| Model numbers | 65CS1, R65CS1 |
Product
Cardioblate CryoFlex Surgical Ablation Console
Reason for recall
There is potential for intermittent electrical connectivity between the console and probe.
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-0273-2022. 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.