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Endologix

FDA adverse event reports naming Endologix as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ENDOLOGIX.

Total reports
3,314
Deaths
187
Injuries
3,083
Malfunctions
43

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Top device categories

Recent recalls

  • 2020-06-11TerminatedProcess control

    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

    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.

  • 2018-10-03TerminatedDevice Design

    ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40, BA22-80/I16-40, BA22-60/I16-40, BA22-40/I16-40, BA22-120/I13-40, BA22-100/I13-40, BA22-80/I13-40, BA22-60/I13-40, BA22-40/I13-40, BA22-110/I20-30, BA22-90/I20-30, BA22-70/I20-30, BA22-50/I20-30, BA22-110/I16-30, BA22-90/I16-30, BA22-70/I16-30, BA22-50/I16-30, BA22-100/I20-55, BA22-80/I20-55, BA22-100/I16-55, BA22-80/I16-55, BA25-120/I20-40, BA25-100/I20-40, BA25-80/I20-40, BA25-60/I20-40, BA25-40/I20-40, BA25-120/I16-40, BA25-100/I16-40, BA25-80/I16-40, BA25-60/I16-40, BA25-40/I16-40, BA25-120/I13-40, BA25-100/I13-40, BA25-80/I13-40, BA25-60/I13-40, BA25-40/I13-40, BA25-110/I20-30, BA25-90/I20-30, BA25-70/I20-30, BA25-50/I20-30, BA25-110/I16-30, BA25-90/I16-30, BA25-70/I16-30, BA25-50/I16-30, BA25-100/I20-55, BA25-80/I20-55, BA25-100/I16-55, BA25-80/I16-55, BA28-120/I20-40, BA28-100/I20-40, BA28-80/I20-40, BA28-60/I20-40, BA28-40/I20-40, BA28-120/I16-40, BA28-100/I16-40, BA28-80/I16-40, BA28-60/I16-40, BA28-40/I16-40, BA28-120/I13-40, BA28-100/I13-40, BA28-80/I13-40, BA28-60/I13-40, BA28-40/I13-40, BA28-110/I20-30, BA28-90/I20-30, BA28-70/I20-30, BA28-50/I20-30, BA28-110/I16-30, BA28-90/I16-30, BA28-70/I16-30, BA28-50/I16-30, BA28-100/I20-55, BA28-80/I20-55, BA28-100/I16-55, BA28-80/I16-55

    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.

  • 2018-10-03TerminatedDevice Design

    ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40, BEA22-60/I16-40, BEA22-40/I16-40, BEA22-120/I13-40, BEA22-100/I13-40, BEA22-80/I13-40, BEA22-60/I13-40, BEA22-40/I13-40, BEA22-110/I20-30, BEA22-90/I20-30, BEA22-70/I20-30, BEA22-50/I20-30, BEA22-110/I16-30, BEA22-90/I16-30, BEA22-70/I16-30, BEA22-50/I16-30, BEA22-100/I20-55, BEA22-80/I20-55, BEA22-100/I16-55, BEA22-80/I16-55, BEA25-120/I20-40, BEA25-100/I20-40, BEA25-80/I20-40, BEA25-60/I20-40, BEA25-40/I20-40, BEA25-120/I16-40, BEA25-100/I16-40, BEA25-80/I16-40, BEA25-60/I16-40, BEA25-40/I16-40, BEA25-120/I13-40, BEA25-100/I13-40, BEA25-80/I13-40, BEA25-60/I13-40, BEA25-40/I13-40, BEA25-110/I20-30, BEA25-90/I20-30, BEA25-70/I20-30, BEA25-50/I20-30, BEA25-110/I16-30, BEA25-90/I16-30, BEA25-70/I16-30, BEA25-50/I16-30, BEA25-100/I20-55, BEA25-80/I20-55, BEA25-100/I16-55, BEA25-80/I16-55, BEA28-120/I20-40, BEA28-100/I20-40, BEA28-80/I20-40, BEA28-60/I20-40, BEA28-40/I20-40, BEA28-120/I16-40, BEA28-100/I16-40, BEA28-80/I16-40, BEA28-60/I16-40, BEA28-40/I16-40, BEA28-120/I13-40, BEA28-100/I13-40, BEA28-80/I13-40, BEA28-60/I13-40, BEA28-40/I13-40, BEA28-110/I20-30, BEA28-90/I20-30, BEA28-70/I20-30, BEA28-50/I20-30, BEA28-110/I16-30, BEA28-90/I16-30, BEA28-70/I16-30, BEA28-50/I16-30, BEA28-100/I20-55, BEA28-80/I20-55, BEA28-100/I16-55, BEA28-80/I16-55

    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.

  • 2018-10-03TerminatedDevice Design

    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

    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.

  • 2018-10-03TerminatedDevice Design

    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

    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.

  • 2017-01-19TerminatedDevice Design

    AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

  • 2017-01-19TerminatedNonconforming Material/Component

    AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

  • 2017-01-19TerminatedDevice Design

    AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA

    Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

  • 2017-01-19TerminatedDevice Design

    AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I16-30 F00820-28 BEA25-120/I20-40 F00820-29 BEA25-100/I20-40 F00820-30 BEA25-80/I20-40 F00820-43 BEA25-110/I20-30 F00820-44 BEA25-90/I20-30 F00820-45 BEA25-70/I20-30 F00820-57 BEA22-80/I20-40 F00820-71 BEA22-90/I20-30 F00820-72 BEA22-70/I20-30 The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA

    Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

  • 2017-01-19TerminatedUnder Investigation by firm

    AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment

    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

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