Device recall
Z-0689-2016: Zilver 518RX Vascular Stent with Rapid Exchange Delivery System
FDA device recall · Class II · Cook Medical Incorporated
Key facts
| Recall number (Z-number) | Z-0689-2016 |
|---|---|
| Recall event | 72965 |
| Product | Zilver 518RX Vascular Stent with Rapid Exchange Delivery System |
| Product code | NIO |
| Recalling firm | Cook Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2017 |
| PMA numbers | P050017, P050017S004 |
| FEI number | 3005580113 |
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