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U.S. Department of Health and Human Services

Class 2 Device Recall Cardica CPort FlexA PLUS Distal Anastomosis System

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 Class 2 Device Recall Cardica CPort FlexA PLUS Distal Anastomosis Systemsee related information
Date Initiated by FirmApril 02, 2018
Date PostedJuly 13, 2018
Recall Status1 Terminated 3 on April 27, 2021
Recall NumberZ-2434-2018
Recall Event ID 80319
510(K)NumberK070548 K073123 
Product Classification Clip, implantable - Product Code FZP
ProductAesDex, 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.
Code Information UDI: (01) 1 18 14900 00150 2 Lot numbers: 141118H, 151026C,  151118B,  160205A,  160805A,  160805B,  161128C,  161111D,  170222L, 170322J,  170712A,  170907D,  171201C,  171207C, 180103B.   
Recalling Firm/
Manufacturer		 AESDEX
900 Saginaw Dr
Redwood City CA 94063-4753
For Additional Information Contact
650-331-7152
Manufacturer 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 2		Under Investigation by firm
ActionAesDex, 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.
Quantity in Commerce400 umits
DistributionU.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FZP
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