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

FDA device recall Z-1037-2017 · posted 2017-01-18 · 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

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.

Root cause

Device Design

Status

Terminated

Product code

MIH

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Port

Date initiated

2016-12-27

Date posted

2017-01-18

Date terminated

2017-04-28

Location

Irvine, CA