Device recall
Z-0904-2025: Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1)…
FDA device recall · Class II · ev3 Inc
Key facts
| Recall number (Z-number) | Z-0904-2025 |
|---|---|
| Recall event | 96006 |
| Product | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6)… |
| Product code | LIT |
| Recalling firm | ev3 Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K141118 |
| FEI number | 2183870 |
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