Device recall
Z-0879-2015: ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx…
FDA device recall · Class II · Ev3, Inc.
Key facts
| Recall number (Z-number) | Z-0879-2015 |
|---|---|
| Recall event | 69965 |
| Product | ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria. |
| Product code | NIM |
| Recalling firm | Ev3, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2015 |
| PMA numbers | P060001 |
| 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