Device recall
Z-1313-2021: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers…
FDA device recall · Class I · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-1313-2021 |
|---|---|
| Recall event | 87490 |
| Product | Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures. |
| Product code | DWA |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K131964 |
| 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