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.
- FOGARTY 120403FPCatheter, Embolectomy1 recall1 report
- FORESIGHT OXIMETER CABLE HEMFSM10Computer, Diagnostic, Programmable1 recall1 report
- Swan-Ganz AIQSGF8Catheter, Flow Directed1 recall1 report
- TRUWAVE T001709ATransducer, Pressure, Catheter Tip1 recall1 report
- TRUWAVE PX2X2TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE, VAMP PLUS PXVP2272TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE PX272TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE PX212TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE PX3X3284CTRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE, VAMP PLUS PXVP2X2AT3TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- SWAN-GANZ TRUE SIZE 132F5CATHETER, FLOW DIRECTED1 recall0 reports
- TRUWAVE, VAMP PXVMP2X22Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PXVMP3X32Catheter, continuous flush1 recall0 reports
- SWAN-GANZ D200F7ELECTRODE, PACEMAKER, TEMPORARY1 recall0 reports
- Fem-Flex II Femoral Arterial Cannula FEMII018ASCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- FLOTRAC MHD85CATHETER, OXIMETER, FIBEROPTIC1 recall0 reports
- TRUWAVE,VAMP PLUS PXVP0041TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TruWave, VAMP Plus PXVPL0111Catheter, Continuous Flush1 recall0 reports
- Acumen IQ AIQS65Transducer, Blood-Pressure, Extravascular1 recall0 reports
- Acumen IQ AIQS6R5Transducer, Blood-Pressure, Extravascular1 recall0 reports
- Acumen IQ AIQS6Transducer, Blood-Pressure, Extravascular1 recall0 reports
- Acumen IQ AIQS6RTransducer, Blood-Pressure, Extravascular1 recall0 reports
- ACUMEN IQ SENSOR AIQS6AZTransducer, Blood-Pressure, Extravascular1 recall0 reports
- Fogarty 120807FPCatheter, Embolectomy1 recall0 reports
- FOGARTY 410235FPBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410236FPBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410405FPBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 120403FSPCatheter, Embolectomy1 recall0 reports
- Fogarty 120803FSPCatheter, Embolectomy1 recall0 reports
- SWAN-GANZ TRUE SIZE 096F6CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- SWAN GANZ SGPT54Catheter, Oximeter, Fiber-Optic1 recall0 reports
- SWAN GANZ SGPT64PCatheter, Oximeter, Fiber-Optic1 recall0 reports
- SWAN-GANZ SGPT755PCatheter, Oximeter, Fiber-Optic1 recall0 reports
- TRUWAVE T001657ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T001658ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T001660ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T321573ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T433803ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T441T01CTransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE PX600FTRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM) T440B26BTransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE, VAMP PXVMP2X21TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE T494C00BTransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE PX4X4TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK1876TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK9146TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE, VAMP PXVK0364Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PXVK0996TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE, VAMP PLUS PXVP1071Catheter, continuous flush1 recall0 reports
- TRUWAVE PXMK1940TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE X 2 (3 CC) /VAMP 88 IN (225 CM) T434501BTransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE, VAMP PXVK0853Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PLUS PXVP1087Catheter, continuous flush1 recall0 reports
- TRUWAVE PXMK2024TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE, VAMP PXVK1099TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK2321TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK2331TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE X 3 (3 CC)/VAMP PLUS (215 CM) T100671MCatheter, Continuous Flush1 recall0 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue2 deaths49 reports
- SWAN-GANZ D97120F5CATHETER, FLOW DIRECTED46 reports
- SAPIEN 3 Ultra RESILIA 9755RSL20Prosthesis, Mitral Valve, Percutaneously Delivered4 deaths44 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFXreplacement Heart-valve42 reports
- EVOQUE 9850EV48USProsthesis, Tricuspid Valve, Percutaneously Delivered3 deaths42 reports
- EVOQUE 9850EV52USProsthesis, Tricuspid Valve, Percutaneously Delivered2 deaths40 reports
- EDWARDS ESHEATH INTRODUCER SET 916ESIntroducer, Catheter3 deaths39 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFXreplacement Heart-valve38 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue1 death37 reports
- SWAN-GANZ D97130F5CATHETER, FLOW DIRECTED36 reports
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFXAortic valve, prosthesis, percutaneously delivered1 death36 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFXreplacement Heart-valve31 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve29 reports
- KONECT RESILIA 11060AHeart-Valve, Non-Allograft Tissue29 reports
- HemoSphere HEMCSM10Computer, Diagnostic, Programmable29 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue29 reports
- Edwards EVOQUE Valve 9850EV56USPercutaneously Delivered Prostheses And Tricuspid Valves1 death29 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFXreplacement Heart-valve28 reports
- FOGARTY HYDRAJAW HYDRA61CLAMP, VASCULAR26 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000replacement Heart-valve26 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue1 death26 reports
- FOGARTY 12TLW405F35CATHETER, EMBOLECTOMY25 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve25 reports
- EDWARDS INTUITY ELITE AORTIC VALVE 8300ABheart-valve, non-allograft tissue24 reports
- KONECT RESILIA 11060AHeart-Valve, Non-Allograft Tissue23 reports
- FOGARTY 12TLW804FCATHETER, EMBOLECTOMY22 reports
- KONECT RESILIA 11060AHeart-Valve, Non-Allograft Tissue1 death22 reports
- EVOQUE 9850EV44USProsthesis, Tricuspid Valve, Percutaneously Delivered2 deaths22 reports
- HemoSphere Alta ALTAALL1Catheter, Oximeter, Fiber-Optic22 reports
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700replacement Heart-valve1 death21 reports
- Smart Pressure Controller PC1QComputer, Diagnostic, Programmable21 reports
- FOGARTY 12TLW803FCATHETER, EMBOLECTOMY19 reports
- CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC 3000replacement Heart-valve19 reports
- CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS 2800TFXReplacement Heart-Valve18 reports
- KONECT RESILIA 11060AHeart-Valve, Non-Allograft Tissue18 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFXreplacement Heart-valve17 reports
- PASCAL PRECISION 20000GSAMitral Valve Repair Devices1 death17 reports
- FOGARTY EVERGRIP EVERGRIP86CLAMP, VASCULAR16 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000replacement Heart-valve16 reports
- EDWARDS INTUITY ELITE AORTIC VALVE 8300ABheart-valve, non-allograft tissue16 reports
- PASCAL 20000ISMitral Valve Repair Devices1 death16 reports
- FOGARTY 120602FCATHETER, EMBOLECTOMY15 reports