Device recall
Z-2042-2021: CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
FDA device recall · Class II · Medtronic Heart Valves Division
Key facts
| Recall number (Z-number) | Z-2042-2021 |
|---|---|
| Recall event | 88113 |
| Product | CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; |
| Product code | NPT |
| Recalling firm | Medtronic Heart Valves Division |
| Recall class | Class II |
| Status | Open, Classified |
| 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