AESDEX: Medical Device Recall in 2018 - (Recall #: Z-2433-2018)

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 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.

Product Classification:

Class II

Date Initiated: April 2, 2018

Date Posted: July 25, 2018

Recall Number: Z-2433-2018

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: 587 units

Code Information:

UDI: (01) 1 18 14900 00100 7. Lot numbers: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated