Prosthesis, mitral valve, percutaneously delivered
FDA product code NPU · Class 3 · 37 devices · 7,367 reports · 376 deaths reported · 5 devices named in recalls
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXEdwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered59 deaths1,124 reports
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered64 deaths1,070 reports
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXEdwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered14 deaths975 reports
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered42 deaths936 reports
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXEdwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall22 deaths733 reports
- SAPIEN 3 Ultra System 9750CM26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered26 deaths531 reports
- SAPIEN 3 Ultra RESILIA 9755RSL29Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered35 deaths321 reports
- SAPIEN 3 Ultra RESILIA 9755RSL26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered18 deaths314 reports
- SAPIEN 3 Ultra System 9750CM23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered22 deaths290 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS29Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall17 deaths225 reports
- SAPIEN 3 Ultra RESILIA 9755RSL23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered20 deaths202 reports
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXEdwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered2 deaths154 reports
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered9 deaths141 reports
- COMMANDER 9750CM29Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered13 deaths139 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall1 death25 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall1 death6 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall5 reports
- SAPIEN 3 Ultra System 9750CM20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered2 deaths55 reports
- SAPIEN 3 Ultra RESILIA 9755RSL20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered4 deaths44 reports
- SAPIEN M3 Dock Steerable Catheter 9880DDSEdwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered12 reports
- EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered9 reports
- EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS29Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 death9 reports
- Edwards Certitude Delivery System 9630TA26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered9 reports
- EDWARDS CERTITUDE INTRODUCER SHEATH SET 9600IS21Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered6 reports
- Tendyne™ TENDV-LP-29SSt. Jude Medical, Inc. · Prosthesis, mitral valve, percutaneously delivered1 death6 reports
- Edwards Certitude Delivery System 9630TA23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered5 reports
- Edwards Certitude Delivery System 9630TA29Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered4 reports
- EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered3 reports
- Tendyne™ TENDV-LP-29LSt. Jude Medical, Inc. · Prosthesis, mitral valve, percutaneously delivered2 deaths3 reports
- EDWARDS CERTITUDE INTRODUCER SHEATH SET 9600IS18Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered2 reports
- Tendyne™ TENDV-LP-35MSt. Jude Medical, Inc. · Prosthesis, mitral valve, percutaneously delivered1 death2 reports
- Tendyne™ TENDV-RS2St. Jude Medical, Inc. · Prosthesis, mitral valve, percutaneously delivered2 reports
- Edwards Certitude Delivery System 9630TA20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 report
- Edwards Commander M Delivery System 9880CM29AEdwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 report
- Edwards 23F Guide Sheath 9880GSEdwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 report
- Tendyne™ TENDV-SP-39MSt. Jude Medical, Inc. · Prosthesis, mitral valve, percutaneously delivered1 report
- Tendyne™ TENDV-LP-33SSt. Jude Medical, Inc. · Prosthesis, mitral valve, percutaneously delivered1 report