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Edwards Lifesciences Recalls
95 recalls on record · July 18, 2012 to May 20, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 20, 2026Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Hazard: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software V
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
December 6, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK036
Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
December 6, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284
Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
December 6, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure mo
Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
December 6, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure mo
Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
December 6, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monit
Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
December 6, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravas
Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
November 15, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Hazard: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
September 6, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Hazard: Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.
April 19, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F
Hazard: There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
April 19, 2023Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.
Hazard: There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
November 9, 2022Medical DevicesFDA
Edwards Lifesciences, LLC recalls Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Hazard: Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
November 9, 2022Medical DevicesFDA
Edwards Lifesciences, LLC recalls Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 12080
Hazard: Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
April 6, 2022Medical DevicesFDA
Edwards Lifesciences, LLC recalls FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Hazard: The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment
April 6, 2022Medical DevicesFDA
Edwards Lifesciences, LLC recalls FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Hazard: The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment
August 18, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3,
Hazard: There is a potential for internal leaks within catheters.
August 18, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3,
Hazard: There is a potential for internal leaks within catheters.
August 18, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lu
Hazard: There is a potential for internal leaks within catheters.
August 18, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx
Hazard: There is a potential for internal leaks within catheters.
August 18, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of
Hazard: There is a potential for internal leaks within catheters.
August 18, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of
Hazard: There is a potential for internal leaks within catheters.
July 7, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
Hazard: There is a potential that the pressure tubing may detach from the blood sampling system
July 7, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Hazard: There is a potential that the pressure tubing may detach from the blood sampling system
July 7, 2021Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
Hazard: There is a potential that the pressure tubing may detach from the blood sampling system