Device Recall AFX Endovascular AAA System, Endoleak Type IIIB

The correction is not lot specific. It applies to AFX procedures conducted after July 2015

Cardiovascular Devices

3

Yes

US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.

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).