Edwards Lifesciences, Llc
Irvine, CA
This page shows every FDA and USDA recall linked to Edwards Lifesciences, Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
135
Total Recalls
2007
First Recall
2025
Most Recent
Brand Name: Optisite Arterial Cannula
Product Name: Optisite Arterial Cannula
Model/Catalog Number: OPTI16
Sof...
Jul 10, 2025
· Device
Active
Brand Name: Optisite Arterial Cannula
Product Name: Optisite Arterial Cannula
Model/Catalog Number: OPTI18
Sof...
Jul 10, 2025
· Device
Active
Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII016AS
Software Versi...
Jul 10, 2025
· Device
Active
Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII016A
Software Versio...
Jul 10, 2025
· Device
Active
Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII018A
Software Versio...
Jul 10, 2025
· Device
Active
Brand Name: FEM-FLEXII
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII018AS
Software Versio...
Jul 10, 2025
· Device
Active
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use i...
Nov 29, 2023
· Device
Active
TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180...
Nov 29, 2023
· Device
Active
TruWave with Vamp System Pressure monitoring set,
REF: PXAVMP(3cc)/VAMP 68 in (173cm)
PXAVMP3: x3 (3cc)/VAMP...
Nov 29, 2023
· Device
Active
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular p...
Nov 29, 2023
· Device
Active
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pres...
Nov 29, 2023
· Device
Active
FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular p...
Nov 29, 2023
· Device
Active
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Nov 6, 2023
· Device
Active
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Aug 29, 2023
· Device
Active
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diam...
Apr 12, 2023
· Device
Active
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diame...
Apr 12, 2023
· Device
Active
Fogarty Biliary Balloon Probes Model Number:
410235FP
410405FP
410236FP
Oct 28, 2022
· Device
Active
Fogarty Arterial Embolectomy Catheters Model Number:
120602FP
120403FP
120803FP
120404FP
120804FP
120805FP
12...
Oct 28, 2022
· Device
Active
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Mar 1, 2022
· Device
Active
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Mar 1, 2022
· Device
Active
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Nu...
Jul 9, 2021
· Device
Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diamete...
Jul 9, 2021
· Device
Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm,...
Jul 9, 2021
· Device
Terminated
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of...
Jul 9, 2021
· Device
Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm,...
Jul 9, 2021
· Device
Terminated
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of L...
Jul 9, 2021
· Device
Terminated
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
May 26, 2021
· Device
Terminated
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile...
May 26, 2021
· Device
Terminated
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Ster...
May 26, 2021
· Device
Terminated
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
May 26, 2021
· Device
Terminated
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (...
May 26, 2021
· Device
Terminated
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
May 26, 2021
· Device
Terminated
Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)5746069195...
May 26, 2021
· Device
Terminated
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Steri...
May 26, 2021
· Device
Terminated
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Jul 10, 2020
· Device
Terminated
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable...
May 8, 2020
· Device
Terminated
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Nov 27, 2019
· Device
Terminated
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...
Oct 22, 2019
· Device
Terminated
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29
UD...
Aug 21, 2019
· Device
Terminated
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26
UDI:...
Aug 21, 2019
· Device
Terminated
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23
UDI...
Aug 21, 2019
· Device
Terminated
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20
UD...
Aug 21, 2019
· Device
Terminated
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO...
Jun 11, 2019
· Device
Terminated
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS
Product Usage:
EV1000A Monitor is used to optim...
May 21, 2019
· Device
Terminated
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F
Product Us...
Apr 25, 2019
· Device
Terminated
Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F
Product Usag...
Apr 25, 2019
· Device
Terminated
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7
Product Usage:
The Swan-Ganz Thermodilution...
Jan 31, 2019
· Device
Terminated
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P
Product Usage:
The Swan-Ganz Thermodiluti...
Jan 31, 2019
· Device
Terminated
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7)
Product Usage:
The Swan-...
Jan 31, 2019
· Device
Terminated
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J
Product Usage:
The Swan-Ganz Thermodilutio...
Jan 31, 2019
· Device
Terminated