Endologix: Medical Device Recall in 2017 - (Recall #: Z-1035-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

AFX Endovascular AAA System, Endoleak Type IIIA

Product Classification:

Class II

Date Initiated: December 27, 2016

Date Posted: January 25, 2017

Recall Number: Z-1035-2017

Event ID: 76075

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).

Status: Terminated

Product Quantity: 40,967

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.

Voluntary or Mandated:

Voluntary: Firm initiated