Device recall
Z-0758-2016: 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power…
FDA device recall · Class II · Spectranetics Corp.
Key facts
| Recall number (Z-number) | Z-0758-2016 |
|---|---|
| Recall event | 73098 |
| Product | 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used… |
| Product code | MCW |
| Recalling firm | Spectranetics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2017 |
| 510(k) numbers | K152181 |
| 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