Recall Z-2434-2018— AESDEX

Name: FDA recall Z-2434-2018
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 2 FDA 510(k) clearances: K073123, K070548. 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.. 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

2 on FDA's record

K073123 — CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150Cardica, Inc.·cleared 2007-12-06
K070548 — C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEMCardica, Inc.·cleared 2007-03-29

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 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.

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.