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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

    K082290

    Cited as predicate by: K100826, K111380, K130649, K142321, K161523, K200417

    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
    2021-06-21NAINo action indicatedPenumbra Inc.0
    2021-06-21NAINo action indicatedPenumbra Inc.0
    2017-02-13NAINo action indicatedPenumbra Inc.0
    2017-02-13NAINo action indicatedPenumbra Inc.0
    2016-02-23VAIVoluntary action indicatedPenumbra Inc.0
    2016-02-23VAIVoluntary action indicatedPenumbra Inc.0
    2015-08-04VAIVoluntary action indicatedPenumbra Inc.1
    2015-08-04VAIVoluntary action indicatedPenumbra Inc.1
    2015-07-15VAIVoluntary action indicatedPenumbra Inc.1
    2015-07-15VAIVoluntary action indicatedPenumbra Inc.1
    2014-04-30NAINo action indicatedPenumbra Inc.0
    2014-04-30NAINo action indicatedPenumbra Inc.0
    2012-02-27NAINo action indicatedPenumbra Inc.0
    2012-02-27NAINo action indicatedPenumbra Inc.0
    2010-08-24VAIVoluntary action indicatedPenumbra Inc.1
    2010-08-24VAIVoluntary action indicatedPenumbra Inc.1
    2009-12-31WLWarning LetterPenumbra Inc.—
    2009-12-31WLWarning LetterPenumbra Inc.—
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