AesDex — Class II medical device recall Z-2434-2018
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-2434-2018 |
|---|---|
| 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 | 400 umits |
| Reason classes | foreign material |
| Lot numbers | 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161111D, 161128C, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, 180103B |
| Model numbers | FG-000150 |
Product
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. 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. The system is designed with a flexible shaft to facilitate access to difficult to reach coronary targets.
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-2434-2018. 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.