FDA Medical Device Recalls (openFDA)
Endologix: AFX Endovascular AAA System, Endoleak Type IIIA
- Recall number
- Z-1035-2017
- Recalling firm
- Endologix
- Product
- AFX Endovascular AAA System, Endoleak Type IIIA
- Status
- Terminated
- Initiated
- 2016-12-27
- Posted
- 2017-01-18
- Terminated
- 2017-04-28
- 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).
- 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
- 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.
- Lot, serial or model codes
- The correction is not lot specific. It applies to AFX procedures conducted after June 2013
- 510(k) numbers
- not on file
- PMA numbers
- ["P040002"]
- Product code
- MIH
- Firm FEI
- 3011063223
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28