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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
InitiatedRecall #ClassStatusReasonQuantityLink basis
2010-10-25Z-0428-2011TerminatedReperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.—clearance family
Regulatory clearances

    Predicate lineage

    K072718

    Cited as predicate by: K100769, K113163, K121917, K133317, K142458, K160449, K161506, K222808

    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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