Recall Z-2433-2018— AESDEX

Name: FDA recall Z-2433-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-02

Class II · Terminated

Class II FDA medical device recall by AESDEX, initiated 2018-04-02, terminated 2021-04-27. It names 4 FDA 510(k) clearances: K101018, K090872, K063644 and 1 more. 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.. Reason: 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..

Recalling firm: AESDEX
Classification: Class II
Status: Terminated
Initiated: 2018-04-02
Terminated: 2021-04-27
Firm location: Redwood City, CA, United States

510(k) clearances named in this recall

4 on FDA's record

K101018 — CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100Cardica, Inc.·cleared 2010-06-25
K090872 — MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEMCardica, Inc.·cleared 2009-04-21
K063644 — CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEMCardica, Inc.·cleared 2007-01-11
K053524 — C-PORT DISTAL ANASTOMOSIS SYSTEMCardica, Inc.·cleared 2006-11-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.