FDA Medical Device Recalls (openFDA)
Endologix: AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
- Recall number
- Z-1037-2017
- Recalling firm
- Endologix
- Product
- AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
- Status
- Terminated
- Initiated
- 2016-12-27
- Posted
- 2017-01-18
- Terminated
- 2017-04-28
- Reason
- Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
- Root cause
- Device Design
- Action
- Endologix sent a dear physician letter dated June 2, 2015, to inform them of the enclosed 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 letter informs the Physicians of the year's update on the clinical programs and commercial experience (i.e. post-market surveillance). A dear physician letter dated January 2016 was seen to inform them of the enclosed 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and commercial experience (i.e. 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. A dear physician letter dated December 27, 2016, will be sent to provide important information related to the AFX Endovascular AAA System (AFX System). Endologix is informing the customers of a series of updates to the Instructions for Use (IFU) and modifications to the product. Customers with any questions are instructed to contact their local Endologix representative.
- Quantity
- not on file
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to 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 July 2015
- 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