Home / Recalls / Endologix, Inc. / Z-2263-2020

Z-2263-2020 Class I Terminated

Recalled by Endologix, Inc. — Santa Rosa, CA

Recall Details

Product Type
Devices
Report Date
June 17, 2020
Initiation Date
May 6, 2020
Termination Date
May 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9156

Product Description

Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J

Reason for Recall

A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.

Distribution Pattern

Worldwide DIstribution: U.S (nationwide).: PA, AZ, NY, FL, HI, CA, OR, IL, MS, AR, WI, KY, TX, TN, MO, NJ, MA, MT, VA, MI, CO, WV, NC, NH, NV, CT, ME, WY, OH, OK, IN, UT, AL, WA, GA, SC, KS, LA, NM, MD, DC, NE, SD, RI, IA, VT, ND. and Countries of:: Argentina, Australia, Chile, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Taiwan, Thailand, Canada, Austria, Belgium, Cyprus, Czech Republic, Germany, Hungary, Ireland, Italy, Switzerland, Luxembourg, Netherlands, Poland, Portugal, Romania, Spain, Sweden, and United Kingdom

Code Information

All Lot and Serial Numbers not yet implanted

Other recalls by Endologix, Inc.

  • 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-1039-2017 Class II — AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated (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)