Device recall
Z-0591-2008: AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size…
FDA device recall · Class III · AngioScore Inc.
Key facts
| Recall number (Z-number) | Z-0591-2008 |
|---|---|
| Recall event | 46149 |
| Product | AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA. |
| Product code | NWX |
| Recalling firm | AngioScore Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 25, 2008 |
| 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