fda
2 records
FDA Device Recall: AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Numb
2018-07-25
Class II — 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.
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FDA Device Recall: AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100
2018-07-25
Class II — 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.
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