Home / Recalls / Endologix / Z-1035-2017

Z-1035-2017 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
40,967

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).

Distribution Pattern

Worldwide Distribution - US Distribution and to the countries of : 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 June 2013

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-1048-2017 Class II — AFX Endovascular AAA System Item Number Item Description F0070305 (January 4, 2017)
  • Z-1049-2017 Class II — AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28- (January 4, 2017)
  • Z-1037-2017 Class II — AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated a (December 27, 2016)
  • Z-1047-2017 Class II — AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endov (December 27, 2016)
  • Z-1038-2017 Class II — AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA Syste (December 27, 2016)