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.
Z-2433-2018
Product summary
- Firm
- AESDEX
- Event
- Event 80319
- Status
- Terminated
- Classification
- Class II
- Quantity
- 587 units
- Official record key
device-enforcement:Z-2433-2018
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 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.
Derived failure modes
-
Foreign material or chemical contamination
plastic fragments