medical Class II Updated 2018-07-25

AESDEX recalls AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Cata

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.
Lot/Code Info: UDI: (01) 1 18 14900 00100 7. Lot numbers: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A.
View official government recall

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