FDA Device recall Z-0273-2022
Cardioblate CryoFlex Surgical Ablation Console
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of Cardioblate CryoFlex Surgical Ablation Console by Medtronic Perfusion Systems, citing there is potential for intermittent electrical connectivity between the console and probe.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0273-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-27 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | IL, KS, UT |
Product
Cardioblate CryoFlex Surgical Ablation Console
Reason
There is potential for intermittent electrical connectivity between the console and probe.
Identifiers
| code_info | 1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988…1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988) Serial 1689 (GTIN 00643169183834) Serial CSC-591 (GTIN 00613994867315) Serial CSC055 (GTIN 00613994867315) Serial 10051 (GTIN 00763000014988) 2) Model R65CS1: Serial RCSC-201 (GTIN 00613994981516) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0273-2022%22
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