AFX Endovascular AAA System, Endoleak Type IIIA
FDA Recall #Z-1035-2017 — Class II — December 27, 2016
Product Description
AFX Endovascular AAA System, Endoleak Type IIIA
Reason for Recall
Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and 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
40,967
Distribution
Worldwide Distribution - US Distribution and to the countries of : Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Code Information
The correction is not lot specific. It applies to AFX procedures conducted after June 2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated