Endologix

FDA Regulatory Profile

Summary

Total Recalls
14 (6 Class I)
510(k) Clearances
5
Inspections
14
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2263-2020Class IOvation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TMay 6, 2020
Z-0007-2019Class IENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: July 31, 2018
Z-0009-2019Class IENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model July 31, 2018
Z-0006-2019Class IENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22July 31, 2018
Z-0008-2019Class IENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX ProxJuly 31, 2018
Z-1048-2017Class IIAFX Endovascular AAA System Item Number Item Description F0070305 A2525/C7January 4, 2017
Z-1049-2017Class IIAFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-0January 4, 2017
Z-1039-2017Class IIAFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent December 27, 2016
Z-1037-2017Class IIAFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent GDecember 27, 2016
Z-1038-2017Class IIAFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for enDecember 27, 2016
Z-1054-2017Class IIAFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent GDecember 27, 2016
Z-1035-2017Class IIAFX Endovascular AAA System, Endoleak Type IIIADecember 27, 2016
Z-1047-2017Class IIAFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System iDecember 27, 2016
Z-1436-2013Class IBrand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 10May 13, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K120212AFX INTRODUCER SYSTEMFebruary 9, 2012
K111747ENDOLOGIX AFX INTRODUCER SYSTEMJuly 12, 2011
K110090AFX INTRODUCER SYSTEMMay 26, 2011
K080360ENDOLOGIX VISIFLEX DUAL LUMEN CATHETERApril 8, 2008
K991601DUAL LUMEN CATHETER, MODEL DL-35-90October 28, 1999