Device recall
Z-1123-2008: ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan…
FDA device recall · Class II · Ev3, Inc
Key facts
| Recall number (Z-number) | Z-1123-2008 |
|---|---|
| Recall event | 46693 |
| Product | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-002. ev3 IntraStent DoubleStrut Peripheral Stent, Model Number: S11-36, Catalog Number: 90-1075-002 (not approved within the USA). |
| Product code | FGE |
| Recalling firm | Ev3, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2008 |
| 510(k) numbers | K980290 |
| FEI number | 2183870 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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