Recall Z-1035-2017— Endologix

Name: FDA recall Z-1035-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-27

Class II · Terminated

Class II FDA medical device recall by Endologix, initiated 2016-12-27, terminated 2017-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: AFX Endovascular AAA System, Endoleak Type IIIA. Reason: Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System)..

Recalling firm: Endologix
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Terminated: 2017-04-28
Firm location: Irvine, CA, United States

Product description

AFX Endovascular AAA System, Endoleak Type IIIA

Reason for recall

Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).

Data sourced from openFDA. This site is unofficial and independent of the FDA.