Device recall
Z-1250-2009: Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM…
FDA device recall · Class II · Cardiovascular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1250-2009 |
|---|---|
| Recall event | 51499 |
| Product | Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a… |
| Product code | MCW |
| Recalling firm | Cardiovascular Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 20, 2012 |
| 510(k) numbers | K071427 |
| 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