Device recall
Z-0509-2024: Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159…
FDA device recall · Class II · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-0509-2024 |
|---|---|
| Recall event | 93373 |
| Product | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The… |
| Product code | MCW |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 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