Z-1035-2017Class II

AFX Endovascular AAA System, Endoleak Type IIIA

Name: Z-1035-2017 AFX Endovascular AAA System, Endoleak Type IIIA
Creator: Endologix
Published: 2016-12-27
License: https://open.fda.gov/license/

Endologix LLC / initiated 2016-12-27 / Terminated

FDA source

Endologix began a recall of AFX Endovascular AAA System, Endoleak Type IIIA on 2016-12-27. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1035-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Posted: 2017-01-18
Terminated: 2017-04-28
Recalling firm: Endologix LLC
Product: AFX Endovascular AAA System, Endoleak Type IIIA
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
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 root 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.
Product codes and lots: The correction is not lot specific. It applies to AFX procedures conducted after June 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1035-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1035-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)