Device recall
Z-1780-2010: St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2…
FDA device recall · Class II · St. Jude Medical Atrial Fibrillation Division Inc
Key facts
| Recall number (Z-number) | Z-1780-2010 |
|---|---|
| Recall event | 53611 |
| Product | St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA |
| Product code | OCL |
| Recalling firm | St. Jude Medical Atrial Fibrillation Division Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2012 |
| 510(k) numbers | K080292 |
| FEI number | 2938836 |
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