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

    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
    2025-08-11WLWarning LetterLeMaitre Vascular, Inc.—
    2025-08-11WLWarning LetterLeMaitre Vascular, Inc.—
    2025-04-16OAIOfficial action indicatedLeMaitre Vascular, Inc.8
    2025-04-16OAIOfficial action indicatedLeMaitre Vascular, Inc.8
    2023-05-16VAIVoluntary action indicatedLeMaitre Vascular, Inc.1
    2023-05-16VAIVoluntary action indicatedLeMaitre Vascular, Inc.1
    2023-04-13VAIVoluntary action indicatedLeMaitre Vascular, Inc.4
    2023-04-13VAIVoluntary action indicatedLeMaitre Vascular, Inc.4
    2022-06-15VAIVoluntary action indicatedLeMaitre Vascular, Inc.5
    2022-06-15VAIVoluntary action indicatedLeMaitre Vascular, Inc.5
    2020-08-27NAINo action indicatedLeMaitre Vascular, Inc.0
    2020-08-27NAINo action indicatedLeMaitre Vascular, Inc.0
    2018-02-16NAINo action indicatedLeMaitre Vascular, Inc.0
    2018-02-16NAINo action indicatedLeMaitre Vascular, Inc.0
    2017-08-01NAINo action indicatedLeMaitre Vascular, Inc.0
    2017-08-01NAINo action indicatedLeMaitre Vascular, Inc.0
    2015-01-28VAIVoluntary action indicatedLeMaitre Vascular, Inc.5
    2015-01-28VAIVoluntary action indicatedLeMaitre Vascular, Inc.5
    2013-03-04VAIVoluntary action indicatedLeMaitre Vascular, Inc.3
    2013-03-04VAIVoluntary action indicatedLeMaitre Vascular, Inc.3
    2013-01-25NAINo action indicatedLeMaitre Vascular, Inc.0
    2013-01-25NAINo action indicatedLeMaitre Vascular, Inc.0
    2010-05-11WLWarning LetterLeMaitre Vascular, Inc.—
    2010-05-11WLWarning LetterLeMaitre Vascular, Inc.—
    Similar devices
    Select up to two to place side-by-side with this device.