Device recall
Z-2028-2009: Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI…
FDA device recall · Class II · Cardiovascular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2028-2009 |
|---|---|
| Recall event | 52810 |
| Product | Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial… |
| Product code | MCW |
| Recalling firm | Cardiovascular Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2011 |
| 510(k) numbers | K071427, K090521 |
| 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