Device recall
Z-1771-2017: ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18…
FDA device recall · Class II · Cardiovascular Systems Inc
Key facts
| Recall number (Z-number) | Z-1771-2017 |
|---|---|
| Recall event | 76784 |
| Product | ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within… |
| Product code | MCW |
| Recalling firm | Cardiovascular Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 28, 2017 |
| 510(k) numbers | K151260 |
| FEI number | 3004742232 |
At a glance
- 1–9 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