Endologix Recalls
14 recalls on record · June 19, 2013 to June 17, 2020 · Medical Devices
Recalls by year
13
17
18
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 17, 2020Medical DevicesFDA
Endologix, Inc. recalls Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB268
Hazard: 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.
October 10, 2018Medical DevicesFDA
Endologix recalls ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I1
Hazard: 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.
October 10, 2018Medical DevicesFDA
Endologix recalls ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Inf
Hazard: 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.
October 10, 2018Medical DevicesFDA
Endologix recalls ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40,
Hazard: 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.
October 10, 2018Medical DevicesFDA
Endologix recalls ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40,
Hazard: 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.
January 25, 2017Medical DevicesFDA
Endologix recalls AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classificatio
Hazard: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
January 25, 2017Medical DevicesFDA
Endologix recalls AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40
Hazard: Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
January 25, 2017Medical DevicesFDA
Endologix recalls AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308
Hazard: Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
January 25, 2017Medical DevicesFDA
Endologix recalls AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endov
Hazard: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
January 25, 2017Medical DevicesFDA
Endologix recalls AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classificati
Hazard: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
January 25, 2017Medical DevicesFDA
Endologix recalls AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment
Hazard: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
January 25, 2017Medical DevicesFDA
Endologix recalls AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classificatio
Hazard: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
January 25, 2017Medical DevicesFDA
Endologix recalls AFX Endovascular AAA System, Endoleak Type IIIA
Hazard: Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
June 19, 2013Medical DevicesFDA
Endologix Inc recalls Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Us
Hazard: Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.