Edwards Lifesciences LLC
407 devices · 16,738 adverse event reports · 488 deaths reported · 111 devices named in recalls
Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXProsthesis, Mitral Valve, Percutaneously Delivered59 deaths1,124 reports
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX26Prosthesis, Mitral Valve, Percutaneously Delivered64 deaths1,070 reports
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXProsthesis, Mitral Valve, Percutaneously Delivered14 deaths975 reports
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX23Prosthesis, Mitral Valve, Percutaneously Delivered42 deaths936 reports
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXProsthesis, Mitral Valve, Percutaneously Delivered1 recall22 deaths733 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXreplacement Heart-valve4 deaths671 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXreplacement Heart-valve1 death656 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXreplacement Heart-valve5 deaths533 reports
- Edwards eSheath+ Introducer set 914ESPIntroducer, Catheter22 deaths532 reports
- SAPIEN 3 Ultra System 9750CM26Prosthesis, Mitral Valve, Percutaneously Delivered26 deaths531 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXreplacement Heart-valve1 death425 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue2 deaths404 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXreplacement Heart-valve1 death391 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue385 reports
- SAPIEN 3 Ultra RESILIA 9755RSL29Prosthesis, Mitral Valve, Percutaneously Delivered35 deaths321 reports
- SAPIEN 3 Ultra RESILIA 9755RSL26Prosthesis, Mitral Valve, Percutaneously Delivered18 deaths314 reports
- Edwards eSheath+ Introducer set 916ESPIntroducer, Catheter18 deaths298 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXreplacement Heart-valve1 death290 reports
- SAPIEN 3 Ultra System 9750CM23Prosthesis, Mitral Valve, Percutaneously Delivered22 deaths290 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS29Prosthesis, Mitral Valve, Percutaneously Delivered1 recall17 deaths225 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXreplacement Heart-valve260 reports
- Fogarty 120804FPCatheter, Embolectomy1 recall1 death200 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXreplacement Heart-valve2 deaths229 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue1 death223 reports
- SAPIEN 3 Ultra RESILIA 9755RSL23Prosthesis, Mitral Valve, Percutaneously Delivered20 deaths202 reports
- SWAN-GANZ CCOMBO V 777F8CATHETER, FLOW DIRECTED2 recalls92 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue2 deaths158 reports
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXProsthesis, Mitral Valve, Percutaneously Delivered2 deaths154 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXreplacement Heart-valve2 deaths142 reports
- SWAN-GANZ CCOMBO V 774F75CATHETER, FLOW DIRECTED2 recalls2 deaths41 reports
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX20Prosthesis, Mitral Valve, Percutaneously Delivered9 deaths141 reports
- COMMANDER 9750CM29Prosthesis, Mitral Valve, Percutaneously Delivered13 deaths139 reports
- HemoSphere HEM1Catheter, Oximeter, Fiberoptic1 recall65 reports
- FOGARTY 120404FPCatheter, Embolectomy1 recall61 reports
- EDWARDS ESHEATH INTRODUCER SET 914ESIntroducer, Catheter6 deaths104 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXreplacement Heart-valve97 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXreplacement Heart-valve95 reports
- Fogarty 120805FPCatheter, Embolectomy1 recall45 reports
- FOGARTY 12TLW805F35CATHETER, EMBOLECTOMY1 recall44 reports
- TRUWAVE PX260TRANSDUCER, PRESSURE, CATHETER TIP1 recall29 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS26Prosthesis, Mitral Valve, Percutaneously Delivered1 recall1 death25 reports
- SWAN-GANZ VIP 831F75CATHETER, FLOW DIRECTED1 recall23 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue73 reports
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFXAortic valve, prosthesis, percutaneously delivered1 death68 reports
- PASCAL 20000ISMMitral Valve Repair Devices2 deaths67 reports
- SWAN-GANZ CONTROLCATH C146F7CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall16 reports
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFXAortic valve, prosthesis, percutaneously delivered1 death64 reports
- Acumen IQ Cuff Adult AIQCASystem, Measurement, Blood-Pressure, Non-Invasive64 reports
- SWAN-GANZ 131F7CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall13 reports
- SWAN-GANZ VIP+ 834F75CATHETER, FLOW DIRECTED1 recall12 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue62 reports
- HEMOSPHERE FORESIGHT MODULE HEMFSM10Oximeter, Tissue Saturation1 recall12 reports
- HemoSphere HEMOXSC100Catheter, Oximeter, Fiberoptic1 recall11 reports
- EDWARDS INTUITY ELITE AORTIC VALVE 8300ABheart-valve, non-allograft tissue60 reports
- SWAN-GANZ TRUE SIZE 096F6CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall9 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFXreplacement Heart-valve59 reports
- TRUWAVE, VAMP PLUS PXVP2284AT3TRANSDUCER, PRESSURE, CATHETER TIP1 recall9 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue58 reports
- TRUWAVE, VAMP PXAVMPCatheter, continuous flush1 recall7 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFXreplacement Heart-valve57 reports
- Acumen IQ AIQS85Transducer, Blood-Pressure, Extravascular1 recall7 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS23Prosthesis, Mitral Valve, Percutaneously Delivered1 recall1 death6 reports
- SWAN-GANZ VIP 831F75CATHETER, FLOW DIRECTED1 recall6 reports
- TRUWAVE, VAMP PLUS PXVP2284Catheter, continuous flush1 recall6 reports
- TruWave, VAMP T001744MTransducer, Pressure, Catheter Tip1 recall6 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS20Prosthesis, Mitral Valve, Percutaneously Delivered1 recall5 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve55 reports
- FLOTRAC MHD8COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION1 recall5 reports
- HemoSphere HEMSGM10Catheter, Oximeter, Fiberoptic1 recall5 reports
- SAPIEN 3 Ultra System 9750CM20Prosthesis, Mitral Valve, Percutaneously Delivered2 deaths55 reports
- TRUWAVE, VAMP PLUS PXVP0550Catheter, continuous flush1 recall5 reports
- FLOTRAC, VAMP MHD6AZCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION1 recall4 reports
- SWAN-GANZ VIP 782F75MCatheter, continuous flush1 recall4 reports
- TRUWAVE PXMK2041TRANSDUCER, PRESSURE, CATHETER TIP1 recall4 reports
- SWAN-GANZ HI-SHORE TRUE SIZE 141F7CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall3 reports
- OptiSite Arterial Perfusion Cannula OPTI16CANNULA, CATHETER1 recall3 reports
- EDWARDS INTUITY ELITE AORTIC VALVE 8300ABheart-valve, non-allograft tissue1 death53 reports
- Fogarty 120803FPCatheter, Embolectomy1 recall3 reports
- Fogarty 120602FPCatheter, Embolectomy1 recall3 reports
- TRUWAVE PX284TRANSDUCER, PRESSURE, CATHETER TIP1 recall3 reports
- SWAN-GANZ 131F7Catheter, Intravascular, Diagnostic1 recall2 reports
- SWAN-GANZ TRUE SIZE 151F7CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- SWAN-GANZ TRUE SIZE TS105F5CATHETER, FLOW DIRECTED1 recall2 reports
- Fem-Flex II Femoral Arterial Cannula FEMII016ACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall2 reports
- OptiSite Arterial Perfusion Cannula OPTI18CANNULA, CATHETER1 recall2 reports
- EDWARDS INTUITY ELITE AORTIC VALVE 8300ABheart-valve, non-allograft tissue1 death52 reports
- FLOTRAC, VAMP, TRUWAVE MHD6C502COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION1 recall2 reports
- Fogarty 120806FPCatheter, Embolectomy1 recall2 reports
- THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM 29AP4045Pulmonary Valve Prosthesis Percutaneously Delivered2 deaths52 reports
- EVOQUE 9850TDSUSProsthesis, Tricuspid Valve, Percutaneously Delivered14 deaths52 reports
- TRUWAVE, VAMP PXAVMP3Catheter, continuous flush1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP23X3TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP2260TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP23X3AT3Catheter, continuous flush1 recall2 reports
- SWAN-GANZ CONTROLCATH TRUE SIZE C144F7CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFXreplacement Heart-valve51 reports
- FLOTRAC, VAMP MHD6AZ5COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION1 recall1 report
- ACUMEN IQ SENSOR AIQS6AZ5Transducer, Blood-Pressure, Extravascular1 recall1 report
- Acumen IQ AIQS8Transducer, Blood-Pressure, Extravascular1 recall1 report
- Acumen IQ AIQS8R5Transducer, Blood-Pressure, Extravascular1 recall1 report