Device recall
Z-0662-2017: ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009…
FDA device recall · Class II · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-0662-2017 |
|---|---|
| Recall event | 75617 |
| Product | ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as… |
| Product code | LPC |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2017 |
| 510(k) numbers | K140775 |
| FEI number | 3007284006 |
At a glance
- 1–9 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