Device recall
Z-2863-2017: Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange…
FDA device recall · Class II · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-2863-2017 |
|---|---|
| Recall event | 77474 |
| Product | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions |
| Product code | MCW |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2021 |
| 510(k) numbers | K170059 |
| FEI number | 3007284006 |
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