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Endologix recalls AFX Endovascular AAA System, Endoleak Type IIIA
Recalled January 25, 2017 · FDA recall Z-1035-2017 · Endologix
Hazard
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). · FDA Class II
Units
40,967
Sold at
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.
Description
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).
Product
AFX Endovascular AAA System, Endoleak Type IIIA
Manufacturer(s)
Endologix
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →