Recall Z-2099-2017— Cook Medical Incorporated

Class I FDA medical device recall by Cook Medical Incorporated, initiated 2017-03-22, terminated 2019-02-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " Iliac/femoral anatomy that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.. Reason: There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention..

Recalling firm

Cook Medical Incorporated

Classification

Class I

Status

Terminated

Initiated

2017-03-22

Terminated

2019-02-14

Firm location

Bloomington, IN, United States

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