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FDADecember 27, 2016device

AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

What to do

FDA enforcement status: Terminated

Brands named

endologix

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). — Recall Details · AllClear