FDA Device recall Z-0496-2021
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe t…
- FDA Device
- Class II
- terminated
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class II recall of Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe t… by Medtronic Ats Medical, citing there is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0496-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-12 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Ats Medical |
| Distribution | US |
Product
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.
Reason
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Identifiers
| code_info | Model Number 60CM1, GTIN 00763000114640, Serial Numbers: 18920000, 18920001, 18920002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0496-2021%22
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