Edwards Lifesciences, LLC FDA Recalls

35 recalls on file across devices, 6 of them Class I and 21 still open. Matched by name to EW.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EOClass IIMar 27, 2026Labeling update to provide warning if functionality of the	Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.	Class IIDevices	Mar 27, 2026
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software VClass IMay 14, 2025due to complaints received for 3mm to 4mm section wire expos	due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body	Class IDevices	May 14, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Class IMay 14, 2025due to complaints received for 3mm to 4mm section wire expos	due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body	Class IDevices	May 14, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/AClass IMay 14, 2025due to complaints received for 3mm to 4mm section wire expos	due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body	Class IDevices	May 14, 2025
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Class IMay 14, 2025due to complaints received for 3mm to 4mm section wire expos	due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body	Class IDevices	May 14, 2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software VClass IMay 14, 2025due to complaints received for 3mm to 4mm section wire expos	due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body	Class IDevices	May 14, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Class IMay 14, 2025due to complaints received for 3mm to 4mm section wire expos	due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body	Class IDevices	May 14, 2025
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravasClass IIOct 4, 2023Their is the potential for flushing difficulties during setu	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure tra	Class IIDevices	Oct 4, 2023
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitClass IIOct 4, 2023Their is the potential for flushing difficulties during setu	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure tra	Class IIDevices	Oct 4, 2023
TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284Class IIOct 4, 2023Their is the potential for flushing difficulties during setu	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure tra	Class IIDevices	Oct 4, 2023
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK036Class IIOct 4, 2023Their is the potential for flushing difficulties during setu	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure tra	Class IIDevices	Oct 4, 2023
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure moClass IIOct 4, 2023Their is the potential for flushing difficulties during setu	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure tra	Class IIDevices	Oct 4, 2023
FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure moClass IIOct 4, 2023Their is the potential for flushing difficulties during setu	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure tra	Class IIDevices	Oct 4, 2023
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35Class IISep 7, 2023Inadvertent release of embolectomy catheters that may experi	Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater	Class IIDevices	Sep 7, 2023
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000ISClass IIJul 27, 2023Due to a manufacturing issue, when using valve repair system	Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or t	Class IIDevices	Jul 27, 2023
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F Class IIFeb 14, 2023There is a potential that the distal end of the catheter may	There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when co	Class IIDevices	Feb 14, 2023
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.Class IIFeb 14, 2023There is a potential that the distal end of the catheter may	There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when co	Class IIDevices	Feb 14, 2023
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FPClass IIOct 6, 2022Due to an increase of confirmed latex deterioration complain	Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in	Class IIDevices	Oct 6, 2022
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 12080Class IIOct 6, 2022Due to an increase of confirmed latex deterioration complain	Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in	Class IIDevices	Oct 6, 2022
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10Class IIMar 1, 2022The StO2 values may be inaccurately low when using either th	The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the	Class IIDevices	Mar 1, 2022
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.Class IIMar 1, 2022The StO2 values may be inaccurately low when using either th	The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the	Class IIDevices	Mar 1, 2022
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Class IIJul 9, 2021There is a potential for internal leaks within catheters.	There is a potential for internal leaks within catheters.	Class IIDevices	Jul 9, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Class IIJul 9, 2021There is a potential for internal leaks within catheters.	There is a potential for internal leaks within catheters.	Class IIDevices	Jul 9, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3,Class IIJul 9, 2021There is a potential for internal leaks within catheters.	There is a potential for internal leaks within catheters.	Class IIDevices	Jul 9, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of LuClass IIJul 9, 2021There is a potential for internal leaks within catheters.	There is a potential for internal leaks within catheters.	Class IIDevices	Jul 9, 2021
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, RxClass IIJul 9, 2021There is a potential for internal leaks within catheters.	There is a potential for internal leaks within catheters.	Class IIDevices	Jul 9, 2021
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number ofClass IIJul 9, 2021There is a potential for internal leaks within catheters.	There is a potential for internal leaks within catheters.	Class IIDevices	Jul 9, 2021
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746Class IIMay 26, 2021There is a potential that the pressure tubing may detach fro	There is a potential that the pressure tubing may detach from the blood sampling system	Class IIDevices	May 26, 2021
Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370Class IIMay 26, 2021There is a potential that the pressure tubing may detach fro	There is a potential that the pressure tubing may detach from the blood sampling system	Class IIDevices	May 26, 2021
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520Class IIMay 26, 2021There is a potential that the pressure tubing may detach fro	There is a potential that the pressure tubing may detach from the blood sampling system	Class IIDevices	May 26, 2021
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547Class IIMay 26, 2021There is a potential that the pressure tubing may detach fro	There is a potential that the pressure tubing may detach from the blood sampling system	Class IIDevices	May 26, 2021
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, SteriClass IIMay 26, 2021There is a potential that the pressure tubing may detach fro	There is a potential that the pressure tubing may detach from the blood sampling system	Class IIDevices	May 26, 2021
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, StClass IIMay 26, 2021There is a potential that the pressure tubing may detach fro	There is a potential that the pressure tubing may detach from the blood sampling system	Class IIDevices	May 26, 2021
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)5746069Class IIMay 26, 2021There is a potential that the pressure tubing may detach fro	There is a potential that the pressure tubing may detach from the blood sampling system	Class IIDevices	May 26, 2021
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, SteClass IIMay 26, 2021There is a potential that the pressure tubing may detach fro	There is a potential that the pressure tubing may detach from the blood sampling system	Class IIDevices	May 26, 2021