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.
- CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC 3000replacement Heart-valve15 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFXreplacement Heart-valve15 reports
- EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) 9630PL29APulmonary Valve Prosthesis Percutaneously Delivered15 reports
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700replacement Heart-valve14 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve14 reports
- CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL 6900Preplacement Heart-valve13 reports
- SWAN-GANZ PACING TD CATHETER D205F7Electrode, Pacemaker, Temporary13 reports
- VitaWave VWCASystem, Measurement, Blood-Pressure, Non-Invasive13 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFXreplacement Heart-valve12 reports
- SAPIEN M3 Dock Steerable Catheter 9880DDSProsthesis, Mitral Valve, Percutaneously Delivered12 reports
- SWAN-GANZ TRUE SIZE 123F6CATHETER, FLOW DIRECTED11 reports
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700replacement Heart-valve11 reports
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800replacement Heart-valve11 reports
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800replacement Heart-valve11 reports
- CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL 6900Preplacement Heart-valve11 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFXreplacement Heart-valve11 reports
- EV1000 PC2KPLETHYSMOGRAPH, IMPEDANCE10 reports
- EDWARDS OXIMETRY CENTRAL VENOUS CATHETER X3820SPCATHETER, OXIMETER, FIBEROPTIC10 reports
- TRUWAVE, VAMP PXVMP184TRANSDUCER, PRESSURE, CATHETER TIP10 reports
- FOGARTY 120403FCATHETER, EMBOLECTOMY9 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve9 reports
- CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTIC 2800TFXReplacement Heart-Valve9 reports
- CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS 2800TFXReplacement Heart-Valve9 reports
- EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS26Prosthesis, Mitral Valve, Percutaneously Delivered9 reports
- EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS29Prosthesis, Mitral Valve, Percutaneously Delivered1 death9 reports
- Edwards Certitude Delivery System 9630TA26Prosthesis, Mitral Valve, Percutaneously Delivered9 reports
- ForeSight FSESLOximeter, Tissue Saturation9 reports
- CO-SET+ 93505PROBE, THERMODILUTION9 reports
- FOGARTY CORKSCREW 140806CATHETER, EMBOLECTOMY8 reports
- Edwards Lifesciences EZ Glide Aortic Cannula EZF21ACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS8 reports
- 8 reports
- FOGARTY 120804FCATHETER, EMBOLECTOMY7 reports
- FOGARTY HYDRAJAW HYDRA86CLAMP, VASCULAR7 reports
- CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL 6900Preplacement Heart-valve7 reports
- CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL 6900Preplacement Heart-valve6 reports
- CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL 6900Preplacement Heart-valve6 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFXreplacement Heart-valve6 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFXreplacement Heart-valve6 reports
- EDWARDS CERTITUDE INTRODUCER SHEATH SET 9600IS21Prosthesis, Mitral Valve, Percutaneously Delivered6 reports
- KONECT RESILIA 11060AHeart-Valve, Non-Allograft Tissue6 reports
- FOGARTY 120803FCATHETER, EMBOLECTOMY5 reports
- FOGARTY 12TLW806FCATHETER, EMBOLECTOMY5 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000replacement Heart-valve1 death5 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFXreplacement Heart-valve5 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS 7000TFXreplacement Heart-valve1 death5 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFXreplacement Heart-valve5 reports
- CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC 2700TFXreplacement Heart-valve5 reports
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200RING, ANNULOPLASTY5 reports
- Edwards Certitude Delivery System 9630TA23Prosthesis, Mitral Valve, Percutaneously Delivered5 reports
- TRUWAVE, VAMP PLUS T001691MCatheter, Continuous Flush5 reports
- SWAN-GANZ 70CC2COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION4 reports
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700replacement Heart-valve4 reports
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800replacement Heart-valve4 reports
- FOGARTY 12TLW403FCATHETER, EMBOLECTOMY4 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000replacement Heart-valve4 reports
- Edwards Lifesciences EZ Glide Aortic Cannula EZC21ACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS4 reports
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800TFXreplacement Heart-valve4 reports
- VolumeView VLV8R520PROBE, THERMODILUTION4 reports
- HEMOSPHERE HEMPSC100Adjunctive Predictive Cardiovascular Indicator4 reports
- Edwards Certitude Delivery System 9630TA29Prosthesis, Mitral Valve, Percutaneously Delivered4 reports
- VitaWave VWCA2Computer, Diagnostic, Programmable4 reports
- TRUWAVE, VAMP JR. VMP306PXTRANSDUCER, PRESSURE, CATHETER TIP4 reports
- SWAN-GANZ 110F5CATHETER, FLOW DIRECTED3 reports
- CO-SET+ 93522PROBE, THERMODILUTION3 reports
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800replacement Heart-valve3 reports
- Thin-Flex Single Stage Venous Drainage Cannula TF024O90CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS3 reports
- FOGARTY 120404FCATHETER, EMBOLECTOMY3 reports
- FOGARTY 12TLW404FCATHETER, EMBOLECTOMY3 reports
- FOGARTY 12TLW807FCATHETER, EMBOLECTOMY3 reports
- EDWARDS BOVINE PERICARDIAL PATCH 4700PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE3 reports
- Edwards Lifesciences EZ Glide Aortic Cannula EZS21TACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS3 reports
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200RING, ANNULOPLASTY3 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve3 reports
- EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS23Prosthesis, Mitral Valve, Percutaneously Delivered3 reports
- Swan Ganz Catheter 111NX7PCatheter, Flow Directed1 death3 reports
- HemoSphere Tissue Oximetry Module HEMTOM10Oximeter, Tissue Saturation3 reports
- ACUMEN IQ AIQFM10Computer, Diagnostic, Programmable3 reports
- HemoSphere Alta ALTACR1Catheter, Oximeter, Fiber-Optic3 reports
- Edwards Lifesciences EZ Glide Aortic Cannula EZC24ACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS3 reports
- Edwards Lifesciences EZ Glide Aortic Cannula EZC24TACATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS3 reports
- TRUWAVE, VAMP PXVMP172Catheter, continuous flush3 reports
- TRUWAVE PX600ITRANSDUCER, PRESSURE, CATHETER TIP3 reports
- SWAN-GANZ CCOMBO 746F8CATHETER, FLOW DIRECTED2 reports
- CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL 4450RING, ANNULOPLASTY2 reports
- CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC 2625replacement Heart-valve2 reports
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700replacement Heart-valve2 reports
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800replacement Heart-valve2 reports
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800replacement Heart-valve2 reports
- CARPENTIER-EDWARDS BIOPROSTHESIS - MITRAL 6625replacement Heart-valve2 reports
- Edwards Lifesciences Retrograde Cardioplegia Catheter RC2012CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
- ThinFlex Single Stage Venous Drainage Cannula TF022O90CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
- FOGARTY 120805FCATHETER, EMBOLECTOMY2 reports
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800TFXreplacement Heart-valve2 reports
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200RING, ANNULOPLASTY2 reports
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200M28Ring, Annuloplasty2 reports
- EV1000 EV1000ACOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION2 reports
- EV1000 EVHRSSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE2 reports
- 25MM X 4CM X 130CM EDWARDS BALLOON CATHETER 9350BC25Balloon aortic valvuloplasty2 reports
- CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTIC 2800TFXReplacement Heart-Valve2 reports
- EDWARDS CERTITUDE INTRODUCER SHEATH SET 9600IS18Prosthesis, Mitral Valve, Percutaneously Delivered2 reports