BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2433-2018 · Initiated April 2, 2018

    Recall

    Recall Number
    Z-2433-2018
    Event Number
    80319
    Firm
    AESDEX
    FEI Number
    3004114958
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 2, 2018
    Posted
    July 13, 2018
    Terminated
    April 27, 2021
    Address
    900 Saginaw Dr, Redwood City, CA, 94063-4753

    Description

    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.

    Action

    AesDex, LLC initiated a voluntary removal via Advisory Notice that was sent to all consignees in the United States on April 2 and 3, 2018. The Advisory Notice describes the issue, and instructs the consignees to stop any use of any product they may have in their inventory and return any unused product. The notice was sent via FedEx and a response form has been included with the notice in which the consignee is requested to fill-out the response form and return the response form to AesDex via Fax or email.

    Distribution

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

    Quantity

    587 units