Z-2434-2018 Class II Terminated
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
- 400 umits
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.
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 00150 2 Lot numbers: 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161128C, 161111D, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, 180103B.