FDA Device Recalls

Recalls / Firms / Edwards Lifesciences, LLC

Edwards Lifesciences, LLC

166 FDA device recalls on record.

DateClassProductReason
2025-05-14Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A So
2025-05-14Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number
2025-05-14Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number
2025-05-14Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS So
2025-05-14Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS S
2025-05-14Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A So
2023-10-04TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc
2023-10-04FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intra
2023-10-04Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO.
2023-10-04Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravas
2023-10-04TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (
2023-10-04FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intra
2023-09-07Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
2023-07-27PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
2023-02-14Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Ext
2023-02-14Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exte
2022-10-06Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
2022-10-06Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 1
2022-03-01FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit
2022-03-01FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
2021-07-09Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Leng
2021-07-09Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Lengt
2021-07-09Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, N
2021-07-09Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm,
2021-07-09Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Len
2021-07-09Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exteri
2021-05-26Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)574606919
2021-05-26Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, C
2021-05-26Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile
2021-05-26Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only,
2021-05-26Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)5746
2021-05-26Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)
2021-05-26Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)074606
2021-05-26Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only
2020-03-27Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
2019-11-27QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
2019-10-22EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only,
2019-10-07Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oxime
2019-07-09Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630
2019-07-09Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 963
2019-07-09Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 96
2019-07-09Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 96
2019-05-14IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, S
2019-03-28Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Pr
2019-03-28Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F
2019-03-21EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is use
2019-01-22Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 0069
2019-01-16Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple
2018-12-21Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz The
2018-12-21Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Th
2018-12-21Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Ther
2018-12-21Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage:
2018-06-11Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
2018-03-30Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier syste
2017-10-02Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Mo
2017-07-21Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 96
2017-07-06Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent
2015-11-13Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2
2015-11-04Thin-Flex Venous Cannula, Model Number:TF292902A
2015-08-26ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve
2015-05-18ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight
2015-05-05Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary
2015-05-05Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm)
2015-03-23Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manu
2014-10-08Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pou
2014-04-09Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannul
2014-04-09Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 2
2014-01-20Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcathet
2013-11-20Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ER
2013-09-16Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD,
2013-08-26Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For
2013-08-26Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, R
2013-07-31"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached t
2013-07-30Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012,
2013-07-16Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn a
2013-06-19Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held
2013-05-14QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr).
2013-03-26Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter h
2013-03-26Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter h
2013-03-14Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended fo
2013-01-30Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXV
2013-01-25Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage:
2012-06-06Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage:
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who r
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who r
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who r
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who re
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who
2012-05-11Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who re
2011-06-15Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port A
2011-06-15Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LL
2011-01-21Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile E
2010-12-03EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwa
2010-12-03Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edw
2010-10-19Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesci
2010-10-19Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesc
2010-06-25Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Ca
2009-06-22Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in
2009-05-11Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated f
2009-03-16Edwards Lifesciences Aquarius System Model GEF09800.
2009-02-09Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC THROMBOSHIELD (an
2009-02-09Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * He
2009-02-09Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance
2009-02-09Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (
2009-02-09Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients who require h
2009-02-09Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC THROMBOSHIELD
2008-09-12Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64,
2008-06-23Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX1
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-12-05Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0
2007-05-17Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VI
2007-03-19Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80