Device recall
Z-3137-2017: Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal…
FDA device recall · Class II · Medtronic Vascular Galway DBA Medtronic Ireland
Key facts
| Recall number (Z-number) | Z-3137-2017 |
|---|---|
| Recall event | 77976 |
| Product | Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. |
| Product code | LOX |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2020 |
| 510(k) numbers | K143480 |
| FEI number | 3002806434 |
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