Home / Recalls / Endologix / Z-0009-2019

Z-0009-2019 Class I Terminated

Recalled by Endologix — Irvine, CA

FDA device recall Z-0009-2019 was initiated by Endologix on July 31, 2018 and is designated Class I. 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 … The recall status is terminated (terminated April 9, 2024). Affected quantity: 17789.

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
17789

Product Description

ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX Stand Alone I16-16/C55 SA, I16-16/C55F SA, I16-16/C88 SA, I20-13/C70F SA, I20-13/C88F SA, I20-20/C55 SA, I20-20/C55F SA, IS20-25/C55 SA, IF20-25/C65 SA, IS20-25/C65 SA

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

FDA data resources