Device recall
Z-1230-2017: DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral…
FDA device recall · Class II · Cardiovascular Systems Inc
Key facts
| Recall number (Z-number) | Z-1230-2017 |
|---|---|
| Recall event | 76352 |
| Product | DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the… |
| Product code | MCW |
| Recalling firm | Cardiovascular Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2017 |
| 510(k) numbers | K152694 |
| 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