AesDex recalled over possible plastic fragments

Recall date

April 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AESDEX recalls AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A P…

Recall number

Z-2434-2018

FDA classification

Class II

Brand / firm

AESDEX

Sold / distributed

U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.