AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for...
FDA Recall #Z-1038-2017 — Class II — December 27, 2016
Product Description
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).
Reason for Recall
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Recalling Firm
Endologix — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
40967
Distribution
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.
Code Information
The correction is not lot specific. It applies to AFX procedures conducted after July 2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated