Device recall
Z-2048-2016: EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene…
FDA device recall · Class II · Ev3, Inc.
Key facts
| Recall number (Z-number) | Z-2048-2016 |
|---|---|
| Recall event | 74276 |
| Product | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel… |
| Product code | NIP |
| Recalling firm | Ev3, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2017 |
| PMA numbers | P110023 |
| FEI number | 2183870 |
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