# FDA recall Z-2434-2018

> **AESDEX** · Class II · device recall initiated 2018-04-02.

## 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.

## Distribution

U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.

## Key facts

- **Recall number:** Z-2434-2018
- **Recalling firm:** AESDEX
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-02
- **Report date:** 2018-07-25
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redwood City, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2434-2018

## Citation

> AI Analytics. FDA recall Z-2434-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2434-2018. Source: US FDA. Licensed CC0.

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