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Edwards Lifesciences LLC

United States US-MF-000007139 Last updated 23 Oct 2026

Devices
2,009
Registries
EUDAMEDFDA
FDA recalls
17222 ongoing

Catalogue2,009

Page 1 of 40

Showing 1-50 of 2,009

EUDAMED certificates4

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (4)

Notified body 0344 2 certificates

  • 3828128TD05 Supplemented

    Technical documentation EU MDR

    Issued
    8 Jul 2025
    Expires
    13 Oct 2028
    Reason
    Other
  • 3828128TD02 Amended

    Technical documentation EU MDR

    Issued
    13 Apr 2023
    Expires
    4 Aug 2027
    Reason
    Mnf ar change

TÜV SÜD Product Service GmbH 0123 2 certificates

  • G70 039555 0224 Supplemented

    Technical documentation EU MDR

    Issued
    16 Jun 2026
    Expires
    10 Apr 2030
    Reason
    Add device or group
  • G15 039555 0237 Supplemented

    Quality management system EU MDR

    Issued
    17 Jun 2026
    Expires
    1 Apr 2030
    Reason
    Other

Related companies

Notified bodies

FDA recalls172

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 172 recalls.

  • 2026

    • 27 Mar 2026 Z-2172-2026 Class II Ongoing Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.via FDA establishment Edwards Lifesciences

  • 2025

    • 14 May 2025 Z-2080-2025 Class I Ongoing due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.via FDA establishment Edwards Lifesciences
    • 14 May 2025 Z-2081-2025 Class I Ongoing due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.via FDA establishment Edwards Lifesciences
    • 14 May 2025 Z-2082-2025 Class I Ongoing due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.via FDA establishment Edwards Lifesciences
    • 14 May 2025 Z-2083-2025 Class I Ongoing due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.via FDA establishment Edwards Lifesciences
    • 14 May 2025 Z-2084-2025 Class I Ongoing due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.via FDA establishment Edwards Lifesciences
    • 14 May 2025 Z-2085-2025 Class I Ongoing due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.via FDA establishment Edwards Lifesciences

  • 2023

    • 4 Oct 2023 Z-0409-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences
    • 4 Oct 2023 Z-0410-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences
    • 4 Oct 2023 Z-0411-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences
Show the 25 most recent of 172 recalls

  • 2023

    • 4 Oct 2023 Z-0412-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences
    • 4 Oct 2023 Z-0413-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences
    • 4 Oct 2023 Z-0414-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences
    • 7 Sep 2023 Z-0238-2024 Class II Ongoing Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).via FDA establishment Edwards Lifesciences
    • 27 Jul 2023 Z-2479-2023 Class II Ongoing 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.via FDA establishment Edwards Lifesciences
    • 14 Feb 2023 Z-1379-2023 Class II Ongoing 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.via FDA establishment Edwards Lifesciences
    • 14 Feb 2023 Z-1380-2023 Class II Ongoing 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.via FDA establishment Edwards Lifesciences

  • 2022

    • 6 Oct 2022 Z-0146-2023 Class II Ongoing Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.via FDA establishment Edwards Lifesciences
    • 6 Oct 2022 Z-0147-2023 Class II Ongoing Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.via FDA establishment Edwards Lifesciences
    • 1 Mar 2022 Z-0834-2022 Class II Ongoing 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 treatmentvia FDA establishment Edwards Lifesciences
    • 1 Mar 2022 Z-0835-2022 Class II Ongoing 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 treatmentvia FDA establishment Edwards Lifesciences

  • 2021

    • 9 Jul 2021 Z-2278-2021 Class II Terminated There is a potential for internal leaks within catheters.via FDA establishment Edwards Lifesciences
    • 9 Jul 2021 Z-2279-2021 Class II Terminated There is a potential for internal leaks within catheters.via FDA establishment Edwards Lifesciences
    • 9 Jul 2021 Z-2280-2021 Class II Terminated There is a potential for internal leaks within catheters.via FDA establishment Edwards Lifesciences
    • 9 Jul 2021 Z-2281-2021 Class II Terminated There is a potential for internal leaks within catheters.via FDA establishment Edwards Lifesciences

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • Edwards Lifesciences Guadalupe Cartago · CR FEI 3015287573
  • Edwards Lifesciences LTD Shannon Clare · IE FEI 3015179394

What Edwards Lifesciences LLC makes

Edwards Lifesciences LLC manufactures single-use and reusable invasive-pressure transducers, electrical connection cables, and arterial blood sampling kits for clinical monitoring. Their portfolio includes open-surgery and transcatheter aortic heart valves, cardiopulmonary bypass cannulae for drainage and return, and pulmonary artery balloon catheters with electrical functionality. Additional products include retrograde cardioplegia catheters, femoral arterial cannulae, and continuous cardiac output monitoring sensors.

The company’s devices are classified under FDA categories Class I, Class II, and Class III, with listings in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States
Address
1, Edwards Way, Irvine, United States
Website
edwards.com
Phone
+1(800)822-9637
PRRC contact
Joe Nuzzolese
EUDAMED SRN
US-MF-000007139
FDA FEI number
2015691
DUNS number
134139174