Device recall
Z-2089-2008: NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog…
FDA device recall · Class II · Boston Scientific Cupertino, Corporation
Key facts
| Recall number (Z-number) | Z-2089-2008 |
|---|---|
| Recall event | 48430 |
| Product | NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp, Natick, MA. |
| Product code | NIM |
| Recalling firm | Boston Scientific Cupertino, Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2008 |
| PMA numbers | P050025 |
| FEI number | 3005231525 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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