Edwards Lifesciences, LLC
Edwards Lifesciences, LLC holds FDA 510(k) medical device clearances, first cleared 1979, most recent 2026, with 95 FDA device recalls on record.
Top product codes for Edwards Lifesciences, LLC
FDA recalls by Edwards Lifesciences, LLC
10 most recent of 95- Z-2172-2026 — Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Z-2084-2025 — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
- Z-2085-2025 — Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
- Z-2080-2025 — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.
- Z-2082-2025 — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
- Z-2081-2025 — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
- Z-2083-2025 — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
- Z-0409-2024 — Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
- Z-0410-2024 — Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
- Z-0413-2024 — TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm),PXMK2041: (3 cc), PXMK2321: (3cc)/48in (122cm), PXMK2331: x4 (3cc)/12 in (30cm), PXMK9146: x 2 (3cc), PXMK1876: x3(3cc), PXVK1099:(3cc)/62in (157cm), PXMK0102: x2 (3cc)/84in (213cm), PXMK2043:X3(3CC), T001657A: x2 (3cc)/210cm, T001658A: x2 (3cc)/180 cm, T001660A: X3 (3CC)/150CM, T001709A: X2 (3 cc)/210 cm,T001767A: (3cc)/60in (150cm), T321573A: (3cc)/66 in (165cm), T433803A (3cc)/200cm, T441T01C: (3cc)/225 cm, T494C00B: (3 cc)/180 cm,
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Edwards Lifesciences, LLC
1–100 of 136- K251326 — Respiration Rate algorithm
- K253186 — HemoSphere Nano Monitor (HSNANO1)
- K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)
- K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)
- K242518 — Hypertension Prediction Index (HePI) Algorithm
- K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- K240078 — Fogarty Thru-Lumen Embolectomy Catheter
- K233984 — Acumen Assisted Fluid Management (AFM) Software Feature
- K233824 — Swan-Ganz catheter
- K233819 — Fogarty Venous Thrombectomy Catheters
- K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin
- K232294 — HemoSphere Alta Advanced Monitoring Platform +3 more
- K230919 — Acumen IQ finger cuff
- K230579 — Smart Wedge algorithm
- K231038 — Global Hypoperfusion Index (GHI) Algorithm
- K231035 — FusedCO Algorithm
- K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
- K230057 — Acumen Hypotension Prediction Index (HPI) Algorithm
- K223651 — Cerebral Adaptive Index (CAI) Algorithm
- K222216 — TruWave Disposable Pressure Transducer
- K221704 — HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
- K221833 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module
- K221528 — Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
- K213682 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote
- K211610 — Fogarty Occlusion Catheter
- K203224 — Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
- K203687 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
- K203490 — FORE-SIGHT ELITE Absolute Tissue Oximeter
- K203131 — EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
- K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
- K200499 — QuickDraw Venous Cannula
- K200358 — Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
- K193466 — Swan-Ganz Catheters
- K193179 — EV1000 Clinical Platform
- K192762 — Physio Flex Annuloplasty Ring
- K192058 — EV1000 Clinical Platform NI, EV1000 Clinical Platform
- K190205 — HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
- K190130 — The ClearSight finger cuffs
- K191089 — Edwards Pressure Cable
- K182245 — EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
- K180881 — HemoSphere Advanced Monitor, HemoSphere Pressure Cable
- K181684 — VAMP Plus Venous/Arterial Blood Management Protection System
- K180275 — VAMP Optima closed blood sampling system
- K173586 — VAMP Venous/Arterial Blood Management Protection System
- DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software
- K172660 — Duravess bovine pericardial vascular patch
- K171996 — TruWave Disposable Pressure Transducer
- K163381 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
- K163693 — IntraClude Intra-Aortic Occlusion Device
- K161962 — VAMP Venous/Arterial Blood Management Protection System
- K160645 — PreSep Oligon Oximetry Catheter
- K160552 — EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
- K160084 — Swan Ganz Catheters
- K152980 — Flo Trac sensor, Volume View sensor
- K152762 — Fogarty Occlusion Catheter
- K152633 — Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
- K150882 — Edwards Suture Fastening System
- K142749 — TruWave Disposable Pressure Transducer
- K141206 — EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
- K141495 — TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
- K140241 — EDWARDS TRANSFEMORAL BALLOON CATHETER
- K140312 — EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
- K131588 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
- K131892 — EV1000 CLINICAL PLATFORM
- K140398 — EMBOL-X INTRODUCER SHEATH
- K131627 — CATHETER INTRODUCER SHEATH
- K140208 — FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
- K132175 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
- K123714 — EDWARDS EMBOL-X INTRODUCER SHEATH
- K122381 — NEXFIN MODEL 2
- K123303 — FEMORAL ACCESS VENOUS CANNULAE
- K123298 — FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
- K123370 — EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
- K123187 — RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA
- K121185 — EDWARDS PERCUTANEOUS SHEATH INTRODUCER
- K113459 — ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
- K120780 — EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
- K113411 — EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
- K113565 — MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
- K120072 — VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
- K113667 — CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
- K113182 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
- K112694 — EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
- K103520 — CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
- K103094 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
- K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
- K110103 — EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
- K100709 — EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
- K100739 — VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
- K102420 — EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
- K093877 — RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
- K093554 — RETROFLEX DILATOR KIT
- K093911 — FOGARTY OCCLUSION CATHETER
- K093730 — PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
- K091709 — MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
- K092509 — EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
- K083623 — CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
- K083191 — DETLOGIX ANNULOPLASTY RING, MODEL: 5100
- K083470 — CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
- K082308 — MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.