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Endologix recalls AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classificati
Recalled January 25, 2017 · FDA recall Z-1039-2017 · Endologix
Hazard
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). · FDA Class II
Units
4,143 devices
Sold at
Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Description
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Product
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Manufacturer(s)
Endologix
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →