Device recall
Z-0165-2013: Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and…
FDA device recall · Class II · Oscor, Inc.
Key facts
| Recall number (Z-number) | Z-0165-2013 |
|---|---|
| Recall event | 63112 |
| Product | Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. |
| Product code | LDF |
| Recalling firm | Oscor, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2013 |
| 510(k) numbers | K831695 |
| FEI number | 1035166 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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