Device recall
Z-1131-2022: Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-1131-2022 |
|---|---|
| Recall event | 90089 |
| Product | Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box. |
| Product code | OCL |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K121767, K200514 |
| FEI number | 1000116158 |
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