Device recall
Z-1593-2021: GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary…
FDA device recall · Class II · W.L. Gore & Associates, Inc.
Key facts
| Recall number (Z-number) | Z-1593-2021 |
|---|---|
| Recall event | 87699 |
| Product | GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree. |
| Product code | FGE |
| Recalling firm | W.L. Gore & Associates, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 16, 2024 |
| 510(k) numbers | K081184 |
| FEI number | 3003910212 |
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