Device recall
Z-0505-2018: Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system…
FDA device recall · Class II · Cardiovascular Systems Inc
Key facts
| Recall number (Z-number) | Z-0505-2018 |
|---|---|
| Recall event | 78897 |
| Product | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. |
| Product code | MCW |
| Recalling firm | Cardiovascular Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2019 |
| 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