Recall Z-2434-2018

Aesdex · initiated April 2, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: UDI: (01) 1 18 14900 00150 2 Lot numbers: 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161128C, 161111D, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, 180103B.

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.

FDA-determined cause: Under Investigation by firm

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.

Details

Recall number
Z-2434-2018
Initiated
April 2, 2018
Posted by FDA
July 13, 2018
Terminated
April 27, 2021
Product code
FZP – Clip, Implantable
Quantity
400 umits
Distribution
U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.
Recalling firm
Aesdex, Redwood City, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2433-2018 Class IIAesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The…Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a… 04/02/2018Terminated