Device recall
Z-1797-2024: Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-1797-2024 |
|---|---|
| Recall event | 94274 |
| Product | Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP Left Heart Vent Catheter… |
| Product code | DWF |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K850385 |
| FEI number | 1000116158 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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