Device recall
Z-0559-2021: Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled…
FDA device recall · Class II · Medtronic Heart Valves Division
Key facts
| Recall number (Z-number) | Z-0559-2021 |
|---|---|
| Recall event | 86681 |
| Product | Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23… |
| Product code | NPT |
| Recalling firm | Medtronic Heart Valves Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 22, 2022 |
| PMA numbers | P130021 |
| 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