Device recall
Z-2952-2011: Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO…
FDA device recall · Class II · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-2952-2011 |
|---|---|
| Recall event | 59382 |
| Product | Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions. |
| Product code | DQY |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 12, 2011 |
| 510(k) numbers | K071226 |
| FEI number | 3007284006 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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