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

FDA device recall Z-1039-2017 · 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

Endologix sent a Dear Phycisicans Letter dated June 2, 2015, to all affected customers to inform them of the enclosed 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter informs the customers of the update reports 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 inform the customers of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. Customers were informed 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 these devices. On 12/27/16, a Dear Physician letter was sent to inform customers of the important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers of 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. The letter informs the customers that at the time of the submission of these modifications to FDA, they were not identified as measures intended to address Type III endoleaks. The on-going Endologix investigation has determined that these changes may help prevent the occurrence of Type III endoleaks reported with the AFX device. Customers with any questions are instructed to contact their Endologix representative.

Root cause

Device Design

Status

Terminated

Product code

MIH

Quantity affected

4,143 devices

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

2017-01-19

Date terminated

2017-04-28

Location

Irvine, CA