AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Na

FDA device recall Z-1054-2017 · posted 2017-01-19 · Terminated

Recall details

Recalling firm

Endologix

Reason for recall

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Action taken

A Dear Physician letter dated 6/2/15 was sent to customers to inform them of the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provided update on the clinical programs and commercial experience (i.e., post-market surveillance). 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 for 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. On 12/27/2016 a Dear Physician letter provides important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers that 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. Customers with any questions are instructed to contact their Endologix representative.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MIH

Quantity affected

17,139 units

Distribution

US, and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, Uni

Date initiated

2016-12-27

Date posted

2017-01-19

Date terminated

2017-04-28

Location

Irvine, CA