Device recall
Z-0842-2011: AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform…
FDA device recall · Class I · AngioScore Inc.
Key facts
| Recall number (Z-number) | Z-0842-2011 |
|---|---|
| Recall event | 57271 |
| Product | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020 |
| Product code | DQY |
| Recalling firm | AngioScore Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 4, 2011 |
| 510(k) numbers | K072225, K080151 |
| FEI number | 3005462046 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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