Skip to content
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

    Predicate lineage

    Cited as predicate by: K110167, K113565

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2024-08-15NAINo action indicatedEdwards Lifesciences, LLC0
    2024-08-15NAINo action indicatedEdwards Lifesciences, LLC0
    2022-12-06NAINo action indicatedEdwards Lifesciences, LLC0
    2022-12-06NAINo action indicatedEdwards Lifesciences, LLC0
    2021-11-19NAINo action indicatedEdwards Lifesciences, LLC0
    2021-11-19NAINo action indicatedEdwards Lifesciences, LLC0
    2019-08-19NAINo action indicatedEdwards Lifesciences, LLC0
    2019-08-19NAINo action indicatedEdwards Lifesciences, LLC0
    2019-06-14VAIVoluntary action indicatedEdwards Lifesciences, LLC3
    2019-06-14VAIVoluntary action indicatedEdwards Lifesciences, LLC3
    2018-02-01NAINo action indicatedEdwards Lifesciences, LLC0
    2018-02-01NAINo action indicatedEdwards Lifesciences, LLC0
    2017-07-14NAINo action indicatedEdwards Lifesciences (Singapore) Pte. Ltd0
    2016-05-20VAIVoluntary action indicatedEdwards Lifesciences, LLC3
    2016-05-20VAIVoluntary action indicatedEdwards Lifesciences, LLC3
    2016-02-12VAIVoluntary action indicatedEdwards Lifesciences, LLC0
    2016-02-12VAIVoluntary action indicatedEdwards Lifesciences, LLC0
    2015-12-17NAINo action indicatedEdwards Lifesciences (Singapore) Pte. Ltd0
    2015-11-20VAIVoluntary action indicatedEdwards Lifesciences, LLC5
    2015-11-20VAIVoluntary action indicatedEdwards Lifesciences, LLC3
    2013-05-24WLWarning LetterEdwards Lifesciences, LLC—
    2013-05-24WLWarning LetterEdwards Lifesciences, LLC—
    2010-03-01WLWarning LetterEdwards Lifesciences, LLC—
    2010-03-01WLWarning LetterEdwards Lifesciences, LLC—
    Similar devices
    Select up to two to place side-by-side with this device.