Device recall
Z-0494-2021: Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3…
FDA device recall · Class II · MEDTRONIC ATS MEDICAL, INC.
Key facts
| Recall number (Z-number) | Z-0494-2021 |
|---|---|
| Recall event | 86666 |
| 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. |
| Product code | OCL |
| Recalling firm | MEDTRONIC ATS MEDICAL, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2024 |
| 510(k) numbers | K123733 |
| FEI number | 3008592544 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database