Device recall
Z-1980-2010: FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1980-2010 |
|---|---|
| Recall event | 55855 |
| Product | FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency… |
| Product code | FGE |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2011 |
| 510(k) numbers | K965147 |
| FEI number | 3001451463 |
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