Device recall
Z-0829-06: IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3…
FDA device recall · Class III · Ev3, Inc
Key facts
| Recall number (Z-number) | Z-0829-06 |
|---|---|
| Recall event | 34357 |
| Product | IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless… |
| Product code | FGE |
| Recalling firm | Ev3, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 26, 2006 |
| 510(k) numbers | K993904 |
| 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