AFX Endovascular AAA System, Endoleak Type IIIA

FDA device recall Z-1035-2017 · posted 2017-01-18 · Terminated

Recall details

Recalling firm

Endologix

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).

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MIH

Quantity affected

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, P

Date initiated

2016-12-27

Date posted

2017-01-18

Date terminated

2017-04-28

Location

Irvine, CA