Device recall
Z-0576-2020: Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter…
FDA device recall · Class II · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-0576-2020 |
|---|---|
| Recall event | 84057 |
| Product | Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA. |
| Product code | NWX |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2020 |
| PMA numbers | P050018 |
| FEI number | 3005462046 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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