Home / Recalls / Endologix / Z-0008-2019

Z-0008-2019 Class I Terminated

Recalled by Endologix — Irvine, CA

Recall Details

Product Type
Devices
Report Date
October 10, 2018
Initiation Date
July 31, 2018
Termination Date
April 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
56503

Product Description

ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A28-28/C95, A31-31/C80, A31-31/C100, A34-34/C80, A34-34/C100; Suprarenal Model #/REF: A22-22/C55-O20, A22-22/C75-O20, A22-22/C95-O20, A25-25/C55-O20, A25-25/C75-O20, A25-25/C95-O20, A28-28/C55-O20, A28-28/C75-O20, A28-28/C95-O20, A31-31/C80-O20, A31-31/C100-O20, A34-34/C80-O20, A34-34/C100-O20; AFX Vela, Infrarenal Model #/REF: A22-22/C55V, A22-22/C75V, A22-22/C95V, A25-25/C55V, A25-25/C75V, A25-25/C95V, A28-28/C55V, A28-28/C75V, A28-28/C95V, A31-31/C80V, A31-31/C100V, A34-34/C80V, A34-34/C100V; Suprarenal Model #/REF: A22-22/C55-O20V, A22-22/C75-O20V, A22-22/C95-O20V, A25-25/C55-O20V, A25-25/C75-O20V, A25-25/C95-O20V, A28-28/C55-O20V, A28-28/C75-O20V, A28-28/C95-O20V, A31-31/C80-O20V, A31-31/C100-O20V, A34-34/C80-O20V, A34-34/C100-O20V

Reason for Recall

Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.

Distribution Pattern

U.S.: PA, VA, CA, AZ, IN, GA, FL, IL, OK, MN, OH, KY, MS, NC, MI, AL, CT, LA, SC, TN, NY, WI, MD, WV, AR, NV, NJ, TX, CO, NE, NM, MA, IA, AK, OR, ME, SD, MO, MT, KS, DE, WA, UT, NH, ND, DC, RI, HI, WY, ID, VT, PR; Foreign (OUS): Canada, Argentina, Australia, Brazil, CHILE , Hong Kong, Japan, South Korea, Philippines, Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom

Code Information

All lots distributed from 03/2011 to present.

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-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-1047-2017 Class II — AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endov (December 27, 2016)
  • Z-1037-2017 Class II — AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated a (December 27, 2016)
  • 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)