FDAApril 2, 2018device
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...
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
11814900001502
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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