Device recall
Z-2105-2008: Boston Scientific Flexima Biliary Stent System, 200 cm long,.035" (0.89 mm)…
FDA device recall · Class III · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-2105-2008 |
|---|---|
| Recall event | 48440 |
| Product | Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210. System is used 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… |
| Product code | FGE |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 11, 2008 |
| 510(k) numbers | K965147 |
| FEI number | 1828132 |
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