Z-1047-2017Class II

AFX Endovascular AAA System, Endoleak Type IIIA

Name: Z-1047-2017 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 / root cause: manufacturing process

FDA source

Endologix began a recall of AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with... on 2016-12-27. FDA classified it as Class II and gives the reason as "Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1047-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Posted: 2017-01-19
Terminated: 2017-04-28
Recalling firm: Endologix LLC
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).
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Root cause tag: manufacturing process
FDA 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.
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.
Product codes and lots: The correction is not lot specific. It applies to AFX procedures conducted after October 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1047-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1047-2017	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)