Device recall
Z-1510-2013: FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-1510-2013 |
|---|---|
| Recall event | 65182 |
| Product | FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. |
| Product code | NIP |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2014 |
| FEI number | 1016427 |
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