Device recall
Z-0912-06: ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery…
FDA device recall · Class II · Ev3, Inc
Key facts
| Recall number (Z-number) | Z-0912-06 |
|---|---|
| Recall event | 34884 |
| Product | ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon. |
| Product code | FGE |
| Recalling firm | Ev3, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 3, 2007 |
| 510(k) numbers | K043243 |
| 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