AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 B

FDA device recall Z-1049-2017 · posted 2017-01-19 · Terminated

Recall details

Recalling firm

Endologix

Reason for recall

Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

Action taken

Endologix sent a Dear Physician letter on 12/30/16 to inform them information related to the AFX Endovascular AAA System (AFX System). The letter provides updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. Customers were informed of the voluntary recall of the small remaining quantity of original AFX with Strata graft material, and the larger diameter sizes of AFX2. Customers with any questions are instructed to contact their Endologix representative. Customers with questions were instructed to call their Endologix representative. On 1/17/17, Endologix issued a press release to inform consumers that firm is resuming shipments of all sizes of AFX2 Endovascular AAA systems and appointed Laura Nagel as Vice President, Global Quality. Consumers are informed that the large diameter sizes of AFX2 were placed on temporary hold on 12/27/16 to investigate a manufacture issue.

Root cause

Device Design

Status

Terminated

Product code

MIH

Quantity affected

832 units

Distribution

Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Fl

Date initiated

2017-01-04

Date posted

2017-01-19

Date terminated

2017-04-28

Location

Irvine, CA