AesDex — Class II medical device recall Z-2433-2018
Terminated recall by AESDEX, reported 2018-07-25. Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a lou
| Recall number | Z-2433-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AESDEX, Redwood City, CA, United States |
| Recall initiated | 2018-04-02 |
| Classified | 2018-07-13 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2021-04-27 |
| Countries outside the US | BE, DE, IT, NL |
| Quantity | 587 units |
| Reason classes | foreign material |
| Lot numbers | 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A |
| Model numbers | FG-000100 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2433-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.