FDA recall Z-2433-2018

AESDEX · Class II · device

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.

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-04-02
Report date
2018-07-25
Termination date
2021-04-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redwood City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2433-2018