Device recall
Z-2143-2020: Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F…
FDA device recall · Class II · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-2143-2020 |
|---|---|
| Recall event | 85477 |
| Product | Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666 |
| Product code | MJN |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 31, 2022 |
| 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