Device recall
Z-2469-2011: Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-2469-2011 |
|---|---|
| Recall event | 58910 |
| Product | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05107. 5mm x 100 mm x 75 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components… |
| Product code | NIP |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 4, 2014 |
| FEI number | 3002095335 |
At a glance
- None Linked 510(k)s
- 10–99 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