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 OXIMETRY CENTRAL VENOUS CATHETER X3820STCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION2 reports
- TruWave, VAMP Plus PXVPL2284Transducer, Pressure, Catheter Tip2 reports
- Physio Flex Annuloplasty Ring 5300Ring, Annuloplasty2 reports
- SWAN-GANZ HEMA70CC2Computer, Diagnostic, Programmable2 reports
- HemoSphere Alta ALTASR1Catheter, Oximeter, Fiber-Optic2 reports
- ForeSight IQ FSESLIQCatheter, Oximeter, Fiber-Optic2 reports
- ESHEATH OPTIMA INTRODUCER SET (14F) 14000ES14Introducer, Catheter2 reports
- VAMP JR. VMP306Catheter, continuous flush2 reports
- VAMP PLUS VP2Catheter, continuous flush2 reports
- TRUWAVE PX284ANTRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE, VAMP PXVMP172AT3Catheter, continuous flush2 reports
- TRUWAVE PX200TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- VAMP 48VMP160Catheter, continuous flush2 reports
- TRUWAVE, VAMP JR. PXVJ0711TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE, VAMP PXVK0670TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE, VAMP PXVMP160Catheter, continuous flush2 reports
- TRUWAVE, VAMP PLUS PXVP0566TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE, VAMP PXVK1102TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS PXVJ050MTransducer, Pressure, Catheter Tip2 reports
- SWAN-GANZ TRUE SIZE 111F7CATHETER, OXIMETER, FIBEROPTIC1 report
- SWAN-GANZ TRUE SIZE 114F7CATHETER, FLOW DIRECTED1 report
- SWAN-GANZ 139F75Catheter, continuous flush1 report
- SWAN-GANZ CCOMBO 744F75CATHETER, FLOW DIRECTED1 report
- SWAN-GANZ PACEPORT 931F75CATHETER, OXIMETER, FIBEROPTIC1 report
- CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL 4450RING, ANNULOPLASTY1 report
- CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL 4450RING, ANNULOPLASTY1 report
- COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD 4600RING, ANNULOPLASTY1 report
- COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD 4600RING, ANNULOPLASTY1 report
- COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD 4600RING, ANNULOPLASTY1 report
- Edwards Lifesciences Vent Catheter E063CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Fem-Flex II Femoral Arterial Cannula FEMII020ACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Edwards Lifesciences Retrograde Cardioplegia Catheter RC014ITCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Edwards Lifesciences Retrograde Cardioplegia Catheter RC2014LBCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Edwards Lifesciences Retrograde Cardioplegia Catheter RC2014MCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Edwards Lifesciences Retrograde Cardioplegia Catheter RC2014MIBBCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Edwards Lifesciences Retrograde Cardioplegia Catheter RC2014SCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- ThinFlex Single Stage Venous Drainage Cannula TF010O90CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- ThinFlex Single Stage Venous Drainage Cannula TF014O90CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Thin-Flex Single Stage Venous Drainage Cannula TF028LCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Thin-Flex Single Stage Venous Drainage Cannula TF028O90CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- FOGARTY CORKSCREW 140808CATHETER, EMBOLECTOMY1 report
- FOGARTY 120803FSCATHETER, EMBOLECTOMY1 report
- FOGARTY 220804FCATHETER, IRRIGATION1 report
- FOGARTY 620404FCatheter, intravascular occluding, temporary1 report
- FOGARTY 62080814FCatheter, intravascular occluding, temporary1 report
- FOGARTY SOFTJAW CSOFT6CLAMP, VASCULAR1 report
- FOGARTY SOFTJAW SOFT33CLAMP, VASCULAR1 report
- Edwards Lifesciences Femoral Venous Cannula VFEM018CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Edwards Lifesciences Femoral Venous Cannula VFEM022CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- CARPENTIER-EDWARDS S.A.VBIOPROSTHESIS - AORTIC 2650replacement Heart-valve1 report
- TRUWAVE MK2220TRANSDUCER, PRESSURE, CATHETER TIP1 report
- SWAN-GANZ PACEPORT 991F8Catheter, continuous flush1 report
- AViD Dual Stage Venous Drainage Cannula TF293702ACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING WITH HOLDER 4100RING, ANNULOPLASTY1 report
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS 7000TFXreplacement Heart-valve1 report
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS 7000TFXreplacement Heart-valve1 report
- Edwards Lifesciences EZ Glide Aortic Cannula EZC21TACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Edwards Lifesciences EZ Glide Aortic Cannula EZF24ACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800TFXreplacement Heart-valve1 report
- FOGARTY 12TLW1203FCATHETER, EMBOLECTOMY1 report
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200RING, ANNULOPLASTY1 report
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200RING, ANNULOPLASTY1 report
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200RING, ANNULOPLASTY1 report
- EDWARDS MC3 TRICUSPID ANNULOPLASTY RING 4900TRING, ANNULOPLASTY1 report
- ThruPort Systems QuickDraw Venous Cannula with Insertion Kit QD22CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING 6200TRING, ANNULOPLASTY1 report
- ThruPort Systems EndoReturn Arterial Cannula Kit ER21BCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- EDWARDS DILATOR KIT 9100DKSADILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- EV1000 EVPMPSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE1 report
- CLEARSIGHT CSCSPLETHYSMOGRAPH, IMPEDANCE1 report
- CLEARSIGHT CSCMSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE1 report
- CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS 2800TFXReplacement Heart-Valve1 report
- FLOTRAC MHD6CATHETER, OXIMETER, FIBEROPTIC1 report
- FLOTRAC MHD65COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION1 report
- TRUWAVE PX1800TRANSDUCER, PRESSURE, CATHETER TIP1 report
- SWAN-GANZ PACEPORT 780F75MCatheter, continuous flush1 report
- EDWARDS OXIMETRY CENTRAL VENOUS CATHETER X3820KTDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- PEDIASAT XT245SPCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION1 report
- PEDIASAT XT245KTPDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- TRUWAVE/ VAMP PLUS PXVPL0030Catheter, Continuous Flush1 report
- HEMOSPHERE HEMDPT1000Adjunctive Predictive Cardiovascular Indicator1 report
- VAMP Jr VJ0095Catheter, Continuous Flush1 report
- Acumen IQ AIQS6C502Transducer, Blood-Pressure, Extravascular1 report
- Edwards Certitude Delivery System 9630TA20Prosthesis, Mitral Valve, Percutaneously Delivered1 report
- Acumen IQ Cuff AIQCSSystem, Measurement, Blood-Pressure, Non-Invasive1 report
- Acumen IQ Cuff AIQCMSystem, Measurement, Blood-Pressure, Non-Invasive1 report
- FORESIGHT ELITE FSEO2004Oximeter, Tissue Saturation1 report
- TruWave PXVPZ10025Transducer, Pressure, Catheter Tip1 report
- HemoSphere Vita HEMPC2KSystem, Measurement, Blood-Pressure, Non-Invasive1 report
- Edwards Commander M Delivery System 9880CM29AProsthesis, Mitral Valve, Percutaneously Delivered1 report
- Edwards 23F Guide Sheath 9880GSProsthesis, Mitral Valve, Percutaneously Delivered1 report
- ESHEATH OPTIMA 14000ES16AIntroducer, Catheter1 report
- VAMP JR. VMP406Catheter, continuous flush1 report
- TRUWAVE, VAMP T001741ATransducer, Pressure, Catheter Tip1 report
- TRUWAVE, VAMP T005048BTransducer, Pressure, Catheter Tip1 report
- CO-SET+ 93600PROBE, THERMODILUTION1 report
- TRUWAVE, VAMP PXVMP260TRANSDUCER, PRESSURE, CATHETER TIP1 report
- TRUWAVE PX36NTRANSDUCER, PRESSURE, CATHETER TIP1 report
- TRUWAVE PX12NTRANSDUCER, PRESSURE, CATHETER TIP1 report
- VAMP 48VMP120Catheter, continuous flush1 report