Device recall
Z-0912-2013: Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate…
FDA device recall · Class II · Atricure Inc
Key facts
| Recall number (Z-number) | Z-0912-2013 |
|---|---|
| Recall event | 64404 |
| Product | Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac… |
| Product code | OCL |
| Recalling firm | Atricure Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 11, 2013 |
| 510(k) numbers | K050459, K061593 |
| FEI number | 3011706110 |
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