Aortic valve, prosthesis, percutaneously delivered
FDA product code NPT · Class 3 · 77 devices · 13,664 reports · 1,131 deaths reported · 12 devices named in recalls
- Evolut™ PRO+ EVPROPLUS-29USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered57 deaths869 reports
- Evolut™ PRO+ EVPROPLUS-34USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered43 deaths613 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-29-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered30 deaths596 reports
- Evolut™ PRO+ EVPROPLUS-26USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered66 deaths578 reports
- Evolut™ FX EVOLUTFX-29Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered47 deaths564 reports
- Evolut™ FX EVOLUTFX-34Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered22 deaths563 reports
- Evolut™ FX D-EVOLUTFX-2329Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered79 deaths555 reports
- Navitor™ NVRO-27St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered1 recall35 deaths471 reports
- Evolut™ FX+ EVFXPLUS-29Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered30 deaths465 reports
- CoreValve™ Evolut™ R EVOLUTR-34-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered24 deaths442 reports
- CoreValve™ Evolut™ R EVOLUTR-34-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered21 deaths436 reports
- Navitor™ NVTR-27St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered1 recall27 deaths360 reports
- Navitor™ NVRO-25St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered32 deaths385 reports
- Evolut™ FX EVOLUTFX-26Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered51 deaths382 reports
- Navitor™ NVRO-29St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered1 recall19 deaths318 reports
- FlexNav™ FNAV-DS-LGSt. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered15 deaths347 reports
- Evolut™ FX+ EVFXPLUS-34Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered7 deaths344 reports
- Evolut™ PRO+ D-EVPROP2329USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered1 recall40 deaths281 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-26-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered26 deaths305 reports
- CoreValve™ Evolut™ R EVOLUTR-29-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered22 deaths300 reports
- Navitor™ NVTR-29St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered1 recall28 deaths249 reports
- Evolut™ FX+ EVFXPLUS-26Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered46 deaths279 reports
- Navitor™ NVTR-25St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered21 deaths279 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-29-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered17 deaths276 reports
- EnVeo™ PRO ENVPRO-16-USMedtronic, Inc. · Aortic valve, prosthesis, percutaneously delivered1 recall23 deaths197 reports
- Evolut™ FX D-EVOLUTFX-2329Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered25 deaths216 reports
- FlexNav™ FNAV-DS-SMSt. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered8 deaths212 reports
- Navitor Titan™ NVRO-35St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered1 recall12 deaths143 reports
- CoreValve™ Evolut™ R EVOLUTR-26-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered11 deaths187 reports
- LOTUS Edge™ Valve System H749LVSUS270Boston Scientific Corporation · Aortic valve, prosthesis, percutaneously delivered1 recall21 deaths118 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-26-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered10 deaths164 reports
- Evolut™ FX D-EVOLUTFX-34Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered16 deaths142 reports
- LOTUS Edge™ Valve System H749LVSUS250Boston Scientific Corporation · Aortic valve, prosthesis, percutaneously delivered1 recall19 deaths91 reports
- Navitor™ NVRO-23St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered11 deaths139 reports
- Evolut™ PRO+ EVPROPLUS-23USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered17 deaths134 reports
- Navitor™ NVTR-23St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered11 deaths129 reports
- LOTUS Edge™ Valve System H749LVSUS230Boston Scientific Corporation · Aortic valve, prosthesis, percutaneously delivered1 recall10 deaths69 reports
- CoreValve™ Evolut™ R EVOLUTR-26-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered10 deaths107 reports
- Evolut™ FX EVOLUTFX-23Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered11 deaths106 reports
- EnVeo™ PRO ENVPRO-14-USMedtronic, Inc. · Aortic valve, prosthesis, percutaneously delivered1 recall4 deaths55 reports
- CoreValve™ Evolut™ R EVOLUTR-23-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered15 deaths105 reports
- CoreValve™ Evolut™ R EVOLUTR-23-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered6 deaths104 reports
- Evolut™ PRO+ D-EVPROP34USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered1 recall9 deaths54 reports
- Evolut™ FX+ EVFXPLUS-23Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered12 deaths88 reports
- CoreValve™ Evolut™ R EVOLUTR-29-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered6 deaths72 reports
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFXEdwards Lifesciences LLC · Aortic valve, prosthesis, percutaneously delivered1 death68 reports
- CoreValve™ Evolut™ MCS-P3-31-AOA-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered65 reports
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFXEdwards Lifesciences LLC · Aortic valve, prosthesis, percutaneously delivered1 death64 reports
- EnVeo™ R ENVEOR-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered5 deaths58 reports
- Portico™ PRT-27St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered8 deaths57 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-23-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered4 deaths55 reports
- Portico™ PRT-25St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered8 deaths53 reports
- Portico™ PRT-29St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered5 deaths49 reports
- Evolut™ FX D-EVOLUTFX-34Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered38 reports
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFXEdwards Lifesciences LLC · Aortic valve, prosthesis, percutaneously delivered1 death36 reports
- EnVeo™ R ENVEOR-N-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered4 deaths34 reports
- Portico™ PRT-23St. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered5 deaths31 reports
- EnVeo™ R ENVEOR-N-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered8 deaths28 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-23-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered2 deaths25 reports
- CoreValve™ Evolut™ MCS-P3-29-AOA-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered24 reports
- CoreValve™ Evolut™ MCS-P3-26-AOA-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered19 reports
- CoreValve™ Evolut™ MCS-P3-29-AOAMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered2 deaths15 reports
- EnVeo™ R ENVEOR-N-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered3 deaths15 reports
- CoreValve™ Evolut™ MCS-P3-31-AOAMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered13 reports
- CoreValve™ Evolut™ MCS-P3-26-AOAMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered5 reports
- CoreValve™ Evolut™ MCS-P4-23-AOA-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered5 reports
- EnVeo™ R ENVEOR-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered1 death5 reports
- CoreValve™ Evolut™ MCS-P4-23-AOAMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered1 death2 reports
- Evolut™ PRO+ L-EVPROP2329USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered2 reports
- Evolut™ FX L-EVOLUTFX-2329Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered2 reports
- CoreValve™ Evolut™ MCS-P3-29-AOA-USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered1 report
- Evolut™ PRO+ L-EVPROP34USMedtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered1 report
- Evolut™ FX L-EVOLUTFX-2329Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered1 report
- Trilogy Delivery Catheter TRILOGY-DC-LJenavalve Technology, Inc. · Aortic Valve, Prosthesis, Percutaneously Delivered1 report
- Trilogy Transcatheter Heart Valve TRILOGY-THV-LJenavalve Technology, Inc. · Aortic Valve, Prosthesis, Percutaneously Delivered1 report
- FlexNav™ FNAV-LS-LGSt. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered1 report
- Navitor™ NVTR-LS-SMSt. Jude Medical, Inc. · Aortic valve, prosthesis, percutaneously delivered1 report