Device recall
Z-0663-2017: Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the…
FDA device recall · Class II · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-0663-2017 |
|---|---|
| Recall event | 75617 |
| Product | Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended. |
| Product code | MJN |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2017 |
| 510(k) numbers | K140775 |
| 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