Home / Recalls / Endologix / Z-1037-2017

Z-1037-2017 Class II Terminated

Recalled by Endologix — Irvine, CA

Recall Details

Product Type
Devices
Report Date
January 25, 2017
Initiation Date
December 27, 2016
Termination Date
April 28, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Reason for Recall

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

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Code Information

The correction is not lot specific. It applies to AFX procedures conducted after July 2015

Other recalls by Endologix

  • Z-2263-2020 Class I — Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB23 (May 6, 2020)
  • Z-0007-2019 Class I — ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile (July 31, 2018)
  • Z-0009-2019 Class I — ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX L (July 31, 2018)
  • Z-0006-2019 Class I — ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, (July 31, 2018)
  • Z-0008-2019 Class I — ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, (July 31, 2018)
  • Z-1049-2017 Class II — AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28- (January 4, 2017)
  • Z-1048-2017 Class II — AFX Endovascular AAA System Item Number Item Description F0070305 (January 4, 2017)
  • Z-1038-2017 Class II — AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA Syste (December 27, 2016)
  • Z-1054-2017 Class II — AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated a (December 27, 2016)
  • Z-1035-2017 Class II — AFX Endovascular AAA System, Endoleak Type IIIA (December 27, 2016)