Device recall
Z-3106-2017: Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F…
FDA device recall · Class I · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-3106-2017 |
|---|---|
| Recall event | 77934 |
| Product | Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for… |
| Product code | MJN |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 14, 2020 |
| 510(k) numbers | K153530 |
| 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