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U.S. Department of Health and Human Services

Class 2 Device Recall Cardica CPort xA PLUS Anastomosis System

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  Class 2 Device Recall Cardica CPort xA PLUS Anastomosis System see related information
Date Initiated by Firm April 02, 2018
Date Posted July 13, 2018
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-2433-2018
Recall Event ID 80319
510(K)Number K053524  K063644  K090872  K101018  
Product Classification Clip, implantable - Product Code FZP
Product 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.
Code Information UDI: (01) 1 18 14900 00100 7. Lot numbers: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A. 
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
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.
Quantity in Commerce 587 units
Distribution U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FZP and Original Applicant = CARDICA, INC.
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