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

Recalled July 25, 2018 · FDA recall Z-2433-2018 · AESDEX

Hazard

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 Class II

Units

587 units

Sold at

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

Description

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.

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.

Manufacturer(s)

AESDEX

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →