Device recall
Z-2264-2015: EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C…
FDA device recall · Class I · Medtronic Cardiovascular Surgery-the Heart Valve Division
Key facts
| Recall number (Z-number) | Z-2264-2015 |
|---|---|
| Recall event | 71719 |
| Product | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system. |
| Product code | NPT |
| Recalling firm | Medtronic Cardiovascular Surgery-the Heart Valve Division |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 20, 2016 |
| 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