Device recall
Z-0389-2007: ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
FDA device recall · Class III · Ev3, Inc
Key facts
| Recall number (Z-number) | Z-0389-2007 |
|---|---|
| Recall event | 37006 |
| Product | ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. |
| Product code | FGE |
| Recalling firm | Ev3, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 3, 2007 |
| 510(k) numbers | K033314 |
| FEI number | 2183870 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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