Device recall
Z-2546-2016: Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C…
FDA device recall · Class II · Medtronic Cardiovascular Surgery-the Heart Valve Division
Key facts
| Recall number (Z-number) | Z-2546-2016 |
|---|---|
| Recall event | 74796 |
| Product | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve. |
| Product code | NPT |
| Recalling firm | Medtronic Cardiovascular Surgery-the Heart Valve Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2017 |
| PMA numbers | P130021, P130021S014 |
| FEI number | 2025587 |
At a glance
- None 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