Z-2433-2018 Class II Terminated
FDA device recall Z-2433-2018 was initiated by AESDEX on April 2, 2018 and is designated Class II. 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. The recall status is terminated (terminated April 27, 2021). Affected quantity: 587 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- April 2, 2018
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 587 units
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.
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 Pattern
U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.
Code Information
UDI: (01) 1 18 14900 00100 7. Lot numbers: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A.