Edwards Lifesciences, LLC

Name: Edwards Lifesciences, LLC Recall Record
Creator: PlainRecalls
License: https://creativecommons.org/publicdomain/zero/1.0/

Compiled from official public sources by the publisher. · Updated September 2026

95 recalls on record · Latest: May 20, 2026

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Agency notice ledger

Federal filing book Edwards Lifesciences, LLC MID-BOOK · SINGLE-AGENCY

#174 of 14,151 · 95 notices · 0.091% archive

BOOK 95 notices
RANK #174 of 14,151
SHARE 0.091% archive
AGENCY FDA Devices (95)
CAT medical devices
CATS 1 category
LATEST May 20, 2026
PHOTO Merge Healthcare, Inc.

Nearest notice-volume peer: Merge Healthcare, Inc. (0 notice gap)

Edwards Lifesciences, LLC accounts for about 0.091% of the 104,423-notice archive on 95 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Edwards Lifesciences, LLC compares to 14,151 recalling firms

Edwards Lifesciences, LLC ranks 174th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Edwards Lifesciences, LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

95 174th of 14151 higher than 13,975 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Medaus, Inc.

96
Edwards Lifes… (this)

95
Merge Healthc…

95
Zydus Pharmac…

95
Accord Health…

94
Olympia Compo…

94

What this shows Edwards Lifesciences, LLC holds about 0.091% of archive notices alongside 95 distinct filings.

FDA Devices Moderate May 20, 2026

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

FDA Devices Critical Jul 16, 2025

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.

FDA Devices Critical Jul 16, 2025

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

FDA Devices Critical Jul 16, 2025

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

FDA Devices Critical Jul 16, 2025

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

FDA Devices Critical Jul 16, 2025

Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

FDA Devices Critical Jul 16, 2025

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

FDA Devices Moderate Dec 6, 2023

Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.

FDA Devices Moderate Dec 6, 2023

TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm),PXMK2041: (3 cc), PXMK2321: (3cc)/48in (122cm), PXMK2331: x4 (3cc)/12 in (30cm), PXMK9146: x 2 (3cc), PXMK1876: x3(3cc), PXVK1099:(3cc)/62in (157cm), PXMK0102: x2 (3cc)/84in (213cm), PXMK2043:X3(3CC), T001657A: x2 (3c

FDA Devices Moderate Dec 6, 2023

FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.

FDA Devices Moderate Dec 6, 2023

TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in (160cm); PXVMP3X32: x3 (3cc)/VAMP 75in (190cm); PXVP0041: (3cc)/VAMP Plus 96in (244cm); PXVP0550: x3 (3cc)/VAMP Plus 91 in (231cm); PXVP1071: x3 (3cc)/VAMP Plus 87in (221cm); PXVP1087: x4(3cc)/VAMP Plus; PXVP2260:

FDA Devices Moderate Dec 6, 2023

FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.

FDA Devices Moderate Dec 6, 2023

Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.

FDA Devices Moderate Nov 15, 2023

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

FDA Devices Moderate Sep 6, 2023

PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS

FDA Devices Moderate Apr 19, 2023

Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)

FDA Devices Moderate Apr 19, 2023

Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)

FDA Devices Moderate Nov 9, 2022

Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP

FDA Devices Moderate Nov 9, 2022

Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP

FDA Devices Moderate Apr 6, 2022

FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.

FDA Devices Moderate Apr 6, 2022

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US

FDA Devices Moderate Jul 7, 2021

Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US

FDA Devices Moderate Jul 7, 2021

Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547

FDA Devices Moderate Jul 7, 2021

Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782

FDA Devices Moderate Jul 7, 2021

Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520

FDA Devices Moderate Jul 7, 2021

Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746

FDA Devices Moderate Jul 7, 2021

Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489

FDA Devices Moderate Jul 7, 2021

Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370

FDA Devices Moderate Jul 7, 2021

Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507

FDA Devices Moderate May 20, 2020

Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

FDA Devices Moderate May 20, 2020

Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.

FDA Devices Moderate Jan 22, 2020

QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705

FDA Devices Moderate Nov 27, 2019

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: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (0069

FDA Devices Critical Aug 28, 2019

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260

FDA Devices Critical Aug 28, 2019

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246

FDA Devices Critical Aug 28, 2019

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253

FDA Devices Critical Aug 28, 2019

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239

FDA Devices Critical Jun 19, 2019

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-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.

FDA Devices Critical May 29, 2019

EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).

FDA Devices Critical May 1, 2019

Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidance and

FDA Devices Critical May 1, 2019

Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidanc

FDA Devices Moderate Apr 17, 2019

Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to th

FDA Devices Moderate Feb 20, 2019

Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system an

FDA Devices Critical Feb 6, 2019

Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination

Edwards Lifesciences, LLC carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (95 here — heavy-book).

Merge Healthcare, Inc. 95 Zydus Pharmaceuticals (USA) Inc 95 Medaus, Inc. 96 Accord Healthcare, INC. 94 Olympia Compounding Pharmacy dba Olympia Pharmacy 94

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Merge Healthcare, Inc. 95 CooperSurgical, Inc. 97 Philips Respironics, Inc. 93 Stradis Medical, LLC dba Stradis Healthcare 93

Frequently Asked Questions

How many federal recall notices name Edwards Lifesciences, LLC? ▼

PlainRecalls indexes 95 distinct federal recall events naming Edwards Lifesciences, LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.

Where does Edwards Lifesciences, LLC sit among other recalling firms? ▼

Edwards Lifesciences, LLC ranks #174 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.

Which agency issues most of Edwards Lifesciences, LLC's notices? ▼

FDA Devices accounts for 95 of this firm's 95 indexed notices.

What product category dominates Edwards Lifesciences, LLC's filing book? ▼

Filings for Edwards Lifesciences, LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.

Is a higher notice count more dangerous? ▼

No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.

Edwards Lifesciences, LLC: 95 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Edwards Lifesciences, LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026