Endologix recalls AFX Endovascular AAA System, Endoleak Type IIIA

Recall date

December 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1035-2017

FDA classification

Class II

Brand / firm

Endologix

Sold / distributed

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.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AFX Endovascular AAA System, Endoleak Type IIIA