Device recall
Z-2155-2014: CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy…
FDA device recall · Class I · Cardiovascular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2155-2014 |
|---|---|
| Recall event | 68806 |
| Product | CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive… |
| Product code | MCW |
| Recalling firm | Cardiovascular Systems, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 1, 2014 |
| 510(k) numbers | K133399 |
| 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