Device product
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.
Z-2434-2018
Product summary
- Firm
- AESDEX
- Event
- Event 80319
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 umits
- Official record key
device-enforcement:Z-2434-2018
Official wording
Reason: 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.
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.
Derived failure modes
-
Foreign material or chemical contamination
plastic fragments