System, Endovascular Graft, Aortic Aneurysm Treatment

FDA product code MIH · Class 3 · 1,312 devices · 11,904 reports · 1,044 deaths reported · 272 devices named in recalls

• TREO Abdominal Stent-Graft System 28-C2-28-040U

  Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-30-040U

  Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-22-055U

  Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-24-055U

  Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-26-055U

  Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-28-070U

  Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-34-210-44U

  Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• Endurant® II ETLW1610C124E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths49 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis CEB231010A

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death49 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT311417

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death48 reports
• AFX2 Bifurcated Endograft System BEA22-90/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths48 reports
• Alto™ Abdominal Stent Graft System TV-AB2380-N

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths48 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281414

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  47 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis HGB161207A

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  47 reports
• AFX2 Bifurcated Endograft System BEA28-90/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  7 deaths47 reports
• AFX2 Bifurcated Endograft System BEA28-120/I20-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths45 reports
• AFX Endovascular AAA System BA28-100/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths44 reports
• Zenith G32551

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths44 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261416

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths43 reports
• AFX Endovascular AAA System BA28-100/I20-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths43 reports
• AFX2 Bifurcated Endograft System BEA28-80/I20-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death43 reports
• AFX2 Bifurcated Endograft System BEA25-90/I20-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths43 reports
• Zenith Spiral-Z G55238

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  42 reports
• Endurant® II ETLW1610C156E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths41 reports
• AFX Endovascular AAA System BA25-100/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death41 reports
• Endurant® II ETBF3216C166E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths40 reports
• GORE EXCLUDER AAA Endoprosthesis PLC201000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths40 reports
• AFX Endovascular AAA System BA25-80/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths40 reports
• Vela Proximal Endograft System A34-34/C80-O20 V

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  39 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281418

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death38 reports
• AFX2 Bifurcated Endograft System BEA28-110/I20-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  38 reports
• Endurant® II ETLW1616C156E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths37 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261414

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  36 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261418

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death36 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281416

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths36 reports
• AFX2 Bifurcated Endograft System BEA28-80/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths36 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT351418

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths35 reports
• AFX Endovascular AAA System I20-13/C88F SA

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  35 reports
• AFX2 Bifurcated Endograft System BEA25-80/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths35 reports
• Endurant® II ETLW1616C93E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths34 reports
• GORE EXCLUDER AAA Endoprosthesis PLC121000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths34 reports
• Endurant® II ETLW1624C124E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths33 reports
• GORE EXCLUDER AAA Endoprosthesis PLC271400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths33 reports
• GORE EXCLUDER AAA Endoprosthesis PLC181200

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death33 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT311415

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death32 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR373715

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths32 reports
• AFX Endovascular AAA System BA25-90/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  31 reports
• AFX Endovascular AAA System BA28-90/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death31 reports
• Zenith Spiral-Z G55242

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  31 reports
• AFX2 Bifurcated Endograft System BEA22-60/I13-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  5 deaths30 reports
• Endurant® II ETLW1613C93E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths29 reports
• GORE EXCLUDER AAA Endoprosthesis PLC231400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death29 reports
• GORE EXCLUDER AAA Endoprosthesis PLC141400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death29 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231414

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths29 reports
• Zenith Spiral-Z G55237

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  29 reports
• Endurant® II ETLW1613C156E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths28 reports
• GORE EXCLUDER AAA Endoprosthesis PLC201400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death28 reports
• GORE EXCLUDER AAA Endoprosthesis PLC141000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths28 reports
• GORE EXCLUDER AAA Endoprosthesis PLC141200

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death28 reports
• GORE EXCLUDER AAA Endoprosthesis PLC231200

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  27 reports
• AFX Endovascular AAA System BA28-120/I20-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  27 reports
• GORE EXCLUDER AAA Endoprosthesis PLC121400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death26 reports
• GORE EXCLUDER AAA Endoprosthesis PLC181400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths26 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR373720

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  26 reports
• GORE TAG Conformable Thoracic Stent Graft TGM343415

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths26 reports
• Vela Proximal Endograft System A34-34/C100 V

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths26 reports
• Vela Proximal Endograft System A28-28/C75-O20 V

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  26 reports
• AFX2 Bifurcated Endograft System BEA22-70/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths26 reports
• Endurant® II ETLW1620C93E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths25 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT351416

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  25 reports
• GORE EXCLUDER AAA Endoprosthesis PLC231000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  25 reports
• AFX2 Bifurcated Endograft System BEA25-80/I20-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  25 reports
• GORE EXCLUDER AAA Endoprosthesis PXC201000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  24 reports
• GORE EXCLUDER AAA Endoprosthesis PLC161200

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death24 reports
• GORE EXCLUDER AAA Endoprosthesis PLC121200

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  24 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT201412

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  24 reports
• Zenith Spiral-Z G55232

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths24 reports
• VALIANT® Captivia VAMF3838C200TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 deaths23 reports
• VALIANT® Captivia VAMF3434C200TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths23 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU373715

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death23 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA360005

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths23 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC083415A

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths23 reports
• AFX2 Bifurcated Endograft System BEA22-80/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths23 reports
• Zenith Flex G48432

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths23 reports
• Zenith Spiral-Z G55243

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  23 reports
• VALIANT® Captivia VAMF3636C200TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 deaths22 reports
• Endurant® II ETLW1628C124E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths22 reports
• GORE EXCLUDER AAA Endoprosthesis PLA360400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  5 deaths22 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231418

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death22 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA280005

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death22 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU454520

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths21 reports
• GORE EXCLUDER AAA Endoprosthesis PLC161000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  21 reports
• GORE EXCLUDER AAA Endoprosthesis PLC201200

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death21 reports
• GORE EXCLUDER AAA Endoprosthesis PLC181000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  21 reports
• GORE EXCLUDER AAA Endoprosthesis PLL161407

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  21 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231416

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death21 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR404010

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths21 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR404020

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death21 reports
• Valiant Navion™ VNMC3434C223TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  21 reports
• AFX Endovascular AAA System BA28-110/I20-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths21 reports