Device recall
Z-2218-2010: AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter…
FDA device recall · Class I · AngioScore Inc.
Key facts
| Recall number (Z-number) | Z-2218-2010 |
|---|---|
| Recall event | 54687 |
| Product | AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and… |
| Product code | NWX |
| Recalling firm | AngioScore Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 21, 2011 |
| 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