Z-2433-2018Class II

AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS...

Name: Z-2433-2018 AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS...
Creator: Aesdex
Published: 2018-04-02
License: https://open.fda.gov/license/

Cardica, Inc. / initiated 2018-04-02 / Terminated

FDA source

AESDEX began a recall of 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... on 2018-04-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2433-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-02
Posted: 2018-07-13
Terminated: 2021-04-27
Recalling firm: Cardica, Inc.
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.
Product code: FZP Clip, Implantable
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 root cause: 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.
Product codes and lots: UDI: (01) 1 18 14900 00100 7. Lot numbers: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2433-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2433-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-13
Z-2434-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-13

Product code FZP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)