Device recall
Z-1887-2019: EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product…
FDA device recall · Class II · AtriCure, Inc.
Key facts
| Recall number (Z-number) | Z-1887-2019 |
|---|---|
| Recall event | 83021 |
| Product | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue… |
| Product code | OCL |
| Recalling firm | AtriCure, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 4, 2020 |
| 510(k) numbers | K142084 |
| 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