FDAApril 2, 2018device
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 c...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
aesdex
UPCs
11814900001007
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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