Class 2 Device Recall AFX Endovascular AAA System, Endoleak Type IIIA

• Date Initiated by Firm: December 27, 2016
• Date Posted: January 18, 2017
• Recall Status: Terminated on April 28, 2017
• Recall Number: Z-1035-2017
• Recall Event ID: 76075
• PMA Number: P040002
• Product Classification: System, endovascular graft, aortic aneurysm treatment - Product Code MIH
• Product: AFX Endovascular AAA System, Endoleak Type IIIA
• Code Information: The correction is not lot specific. It applies to AFX procedures conducted after June 2013
• Recalling Firm/ Manufacturer: Endologix; 35 Hammond; Irvine CA 92618-1607
• Manufacturer 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).
• FDA Determined Cause: Other
• Action: Endologix sent an Dear Physician letter dated June 2, 2015, were sent to customers to inform them that Endologix has enclosed the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). The customer letter includes update on the clinical programs and commercial experience (ie. post-market surveillance). On January 2016, Dear Physician letters were sent to customers to inform them that Endologix has enclosed the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and commercial experience (ie. post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of the devices. The customer letter includes updates on the Clinical Programs and Commercial experience. A Dear Physician letter, "Important Safety Update AFX Endovascular AAA System: Type III Endoleaks", was sent to provide important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers that Endologix has an active post-market surveillance program that has been monitoring and evaluating the performance of the AFX System since its introduction to the market in 2011. In January of 2013, Endologix conducted an investigation into reports of Type IIIa endoleaks (separation of bifurcated and extension stent grafts at the point of overlap), which was followed by an investigation into Type IIIb endoleaks (disruption of the stent graft material) in September of 2013. For further questions please call (949) 595-7200.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MIH and Original Applicant = Endologix, LLC