Device recall
Z-2309-2012: Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended…
FDA device recall · Class II · Cook Ireland Ltd.
Key facts
| Recall number (Z-number) | Z-2309-2012 |
|---|---|
| Recall event | 61451 |
| Product | Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be… |
| Product code | NIO |
| Recalling firm | Cook Ireland Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2013 |
| PMA numbers | P050017 |
| FEI number | 3001845648 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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