AESDEX: Medical Device Recall in 2018 - (Recall #: Z-2434-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 2, 2018

Date Posted: July 25, 2018

Recall Number: Z-2434-2018

Event ID: 80319

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.

Status: Terminated

Product Quantity: 400 umits

Code Information:

UDI: (01) 1 18 14900 00150 2 Lot numbers: 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161128C, 161111D, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, 180103B.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated