medical Class II Updated 2018-07-25

AESDEX recalls AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis

Recalled 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.

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 00150 2 Lot numbers: 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161128C, 161111D, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, 180103B.
View official government recall

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