Device recall
Z-0440-06: Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with…
FDA device recall · Class III · Boston Scientific Scimed
Key facts
| Recall number (Z-number) | Z-0440-06 |
|---|---|
| Recall event | 32924 |
| Product | Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the… |
| Product code | FGE |
| Recalling firm | Boston Scientific Scimed |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 23, 2007 |
| 510(k) numbers | K032025 |
| FEI number | 3002095335 |
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