Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market

Published: 25/08/2017
Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market
Source: WWW.FDA.GOV

Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiat

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