FDA Medical Device Recalls (openFDA)
Endologix: AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
- Recall number
- Z-1047-2017
- Recalling firm
- Endologix
- Product
- AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: 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
- 2017-01-19
- 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
- Nonconforming Material/Component
- Action
- On 6/2/15, a Dear Physician letter was sent to inform their customers of the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provided update reports of the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). On January 2016, a Dear Physician letter was sent to customers to inform them of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The letter provided update reports of 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 these devices. On 12/27/16, a Dear Physician letter will be sent to customers to inform them of the important information related to the AFX Endovascular AAA System (AFX System). The letter provides a series of updates to the Instructions for Use (IFU) and modifications to the product were implemented, including introduction of a graft material processing improvement known as Duraply. Customer are informed of the on-going Endologix investigation that the changes may help prevent the occurrence of Type III endoleaks reported with the AFX device.
- Quantity
- not on file
- Distribution
- US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
- Lot, serial or model codes
- The correction is not lot specific. It applies to AFX procedures conducted after October 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