Brand

Edwards Lifesciences, Llc Recalls

52 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Edwards Lifesciences, Llc.

52Total Recalls
15Critical
1.2MUnits Affected
May 14, 2025Most Recent
All Recalls

Every Edwards Lifesciences, Llc Recall

Sorted by most recent. Click any recall for full details.

52 recalls
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Prod...
Cardiac Devices·27,022 affected·May 14, 2025
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Descrip...
Medical Devices·847 affected·May 14, 2025
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Descript...
Medical Devices·13,240 affected·May 14, 2025
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Surgical Devices·185 affected·Sep 7, 2023
High RiskFDA
Edwards Lifesciences, Llc
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Surgical Devices·92 affected·Jul 27, 2023
High RiskFDA
Edwards Lifesciences, Llc
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable L...
Surgical Devices·326 affected·Feb 14, 2023
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP ...
Surgical Devices·715,620 affected·Oct 6, 2022
High RiskFDA
Edwards Lifesciences, Llc
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Medical Devices·402 affected·Mar 1, 2022
High RiskFDA
Edwards Lifesciences, Llc
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Medical Devices·8,389 affected·Mar 1, 2022
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Steril...
Surgical Devices·152 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommen...
Surgical Devices·178 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recomm...
Surgical Devices·70 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using et...
Medical Devices·290 affected·May 26, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Medical Devices·50 affected·May 26, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Medical Devices·1,679 affected·May 26, 2021
High RiskFDA
Edwards Lifesciences, Llc
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Surgical Devices·597 affected·Mar 27, 2020
High RiskFDA
Edwards Lifesciences, Llc
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Medical Devices·27,168 affected·Nov 27, 2019
High RiskFDA
Edwards Lifesciences, Llc
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 0069...
Medical Devices·62,431 affected·Oct 22, 2019
High RiskFDA
Edwards Lifesciences, Llc
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that ...
Respiratory Devices·35 affected·Oct 7, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Cardiac Devices·1,754 affected·Jul 9, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Cardiac Devices·2,208 affected·Jul 9, 2019
CriticalFDA
Edwards Lifesciences, Llc
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-ao...
Medical Devices·6,552 affected·May 14, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrio...
Cardiac Devices·1,564 affected·Mar 28, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation ...
Cardiac Devices·1,093 affected·Mar 28, 2019
CriticalFDA
Edwards Lifesciences, Llc
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management thr...
Medical Devices·22,443 affected·Mar 21, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Cathete...
Cardiac Devices·875 affected·Dec 21, 2018
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a dia...
Cardiac Devices·459 affected·Dec 21, 2018
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a di...
Cardiac Devices·277 affected·Dec 21, 2018
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a d...
Cardiac Devices·9 affected·Dec 21, 2018
High RiskFDA
Edwards Lifesciences, Llc
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Cardiac Devices·1 affected·Jun 11, 2018
High RiskFDA
Edwards Lifesciences, Llc
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart...
Cardiac Devices·198 affected·Oct 2, 2017
CriticalFDA
Edwards Lifesciences, Llc
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edward...
Cardiac Devices·1,730 affected·Jul 21, 2017
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to ef...
Surgical Devices·200 affected·Jul 6, 2017
High RiskFDA
Edwards Lifesciences, Llc
Thin-Flex Venous Cannula, Model Number:TF292902A
Medical Devices·8,915 affected·Nov 4, 2015
High RiskFDA
Edwards Lifesciences, Llc
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged...
Cardiac Devices·759 affected·Aug 26, 2015
High RiskFDA
Edwards Lifesciences, Llc
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardi...
Cardiac Devices·978 affected·May 5, 2015
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, I...
Medical Devices·5,125 affected·Mar 23, 2015
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII01...
Medical Devices·13,115 affected·Apr 9, 2014
RecallFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical In...
Cardiac Devices·3 affected·Nov 20, 2013
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGF...
Medical Devices·12,034 affected·Sep 16, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Produ...
Medical Devices·80 affected·Aug 26, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are inten...
Surgical Devices·99 affected·Jun 19, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system...
Cardiac Devices·6,117 affected·Mar 26, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system...
Cardiac Devices·5,472 affected·Mar 26, 2013
High RiskFDA
Edwards Lifesciences, Llc
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit ...
Surgical Devices·807 affected·Jan 25, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012