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Recall Observatory FDA recall evidence

Device product

AFX Endovascular AAA System, Endoleak Type IIIA

Z-1035-2017

December 27, 2016

Class II

Product summary

Firm
Endologix
Event
Event 76075
Status
Terminated
Classification
Class II
Quantity
40,967
Official record key
device-enforcement:Z-1035-2017

Official wording

Reason: 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).

Code information: The correction is not lot specific. It applies to AFX procedures conducted after June 2013

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).