AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PL

FDA device recall Z-2434-2018 · posted 2018-07-13 · Terminated

Recall details

Recalling firm

AESDEX

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FZP

Quantity affected

400 umits

Distribution

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

Date initiated

2018-04-02

Date posted

2018-07-13

Date terminated

2021-04-27

Location

Redwood City, CA

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