Edwards Lifesciences recalls
Edwards Lifesciences appears in 95 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnos…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnost…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter p…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences - Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
FDA Device · Class II · 2018-07-25 · Edwards Lifesciences - Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device
FDA Device · Class II · 2018-05-30 · Edwards Lifesciences - Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart C…
FDA Device · Class II · 2018-02-07 · Edwards Lifesciences - Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Cert…
FDA Device · Class I · 2018-01-17 · Edwards Lifesciences - Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectiv…
FDA Device · Class II · 2017-09-06 · Edwards Lifesciences - Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK…
FDA Device · Class II · 2015-12-23 · Edwards Lifesciences - Thin-Flex Venous Cannula, Model Number:TF292902A
FDA Device · Class II · 2015-12-16 · Edwards Lifesciences - ThruPort Knot Pusher
FDA Device · Class II · 2015-09-30 · Edwards Lifesciences - Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System
FDA Device · Class II · 2015-06-17 · Edwards Lifesciences - ClearSight, Model No. EVHRS Heart Reference Sensor
FDA Device · Class II · 2015-06-17 · Edwards Lifesciences - Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75
FDA Device · Class II · 2015-06-10 · Edwards Lifesciences - Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvi…
FDA Device · Class II · 2015-04-08 · Edwards Lifesciences - Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch
FDA Device · Class II · 2014-11-26 · Edwards Lifesciences - Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DF…
FDA Device · Class II · 2014-04-23 · Edwards Lifesciences - Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS,…
FDA Device · Class II · 2014-04-23 · Edwards Lifesciences - Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation
FDA Device · Class II · 2014-02-12 · Edwards Lifesciences - Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip
FDA Device · Class III · 2014-01-01 · Edwards Lifesciences - Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usa…
FDA Device · Class II · 2013-11-13 · Edwards Lifesciences - Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic…
FDA Device · Class II · 2013-11-13 · Edwards Lifesciences - Edwards Lifesciences EMBOL-X Glide Protection System
FDA Device · Class I · 2013-11-06 · Edwards Lifesciences - "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters
FDA Device · Class II · 2013-09-18 · Edwards Lifesciences - Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and…
FDA Device · Class II · 2013-08-21 · Edwards Lifesciences - Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hem…
FDA Device · Class II · 2013-08-21 · Edwards Lifesciences - Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended f…
FDA Device · Class II · 2013-07-24 · Edwards Lifesciences - QuickDraw Venous Cannula with Insertion Kit
FDA Device · Class II · 2013-06-19 · Edwards Lifesciences - Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provid…
FDA Device · Class II · 2013-05-22 · Edwards Lifesciences - Edwards Lifesciences Duraflo coated Femoral Cannula
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences - Edwards Lifesciences Crimpers, Model 9100CR26
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences - Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3,…
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences - Edwards Lifesciences Crimpers, Model 9100CR23
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Edwards Lifesciences Rigid Suction Wand, sterile
FDA Device · Class II · 2012-07-18 · Edwards Lifesciences