Device recall
Z-1586-05: Guidant OTW OMNILINK.018 &.035 Biliary Stent Systems
FDA device recall · Class II · Guidant Endovascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-1586-05 |
|---|---|
| Recall event | 33117 |
| Product | Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems |
| Product code | FGE |
| Recalling firm | Guidant Endovascular Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2012 |
| 510(k) numbers | K011039, K011506, K032530, K033834 |
| FEI number | 2024168 |
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