Device recall
Z-2433-2018: AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100…
FDA device recall · Class II · AESDEX
Key facts
| Recall number (Z-number) | Z-2433-2018 |
|---|---|
| Recall event | 80319 |
| Product | AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel… |
| Product code | FZP |
| Recalling firm | AESDEX |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| 510(k) numbers | K053524, K063644, K090872, K101018 |
| FEI number | 3004114958 |
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