FDA Device recall Z-2433-2018
AesDex, LLC Cardica C-Port xA PLUS Anastomosis System
- FDA Device
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of AesDex, LLC Cardica C-Port xA PLUS Anastomosis System by Aesdex, citing following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2433-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-02 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Aesdex |
| Distribution | n/a |
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 clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount.
Reason
Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
Identifiers
| code_info | UDI: (01) 1 18 14900 00100 7. Lot numbers: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2433-2018%22
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