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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

    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
    2022-06-29VAIVoluntary action indicatedCordis US Corp0
    2022-06-29VAIVoluntary action indicatedCordis US Corp0
    2018-01-12VAIVoluntary action indicatedCordis US Corp1
    2018-01-12VAIVoluntary action indicatedCordis US Corp1
    2017-09-15VAIVoluntary action indicatedAccessClosure, Inc., A Cardinal Health Company1
    2016-07-06NAINo action indicatedCordis US Corp0
    2016-07-06NAINo action indicatedCordis US Corp0
    2016-03-31NAINo action indicatedCordis US Corp0
    2016-03-31NAINo action indicatedCordis US Corp0
    2016-02-12VAIVoluntary action indicatedCardinal Health Mexico 244 S de RL de CV3
    2016-02-01NAINo action indicatedAccessClosure, Inc., A Cardinal Health Company0
    2015-05-08NAINo action indicatedCordis US Corp0
    2015-05-08NAINo action indicatedCordis US Corp0
    2014-08-05VAIVoluntary action indicatedAccessClosure, Inc., A Cardinal Health Company3
    2014-04-03NAINo action indicatedCardinal Health Mexico 244 S de RL de CV0
    2014-01-30NAINo action indicatedCordis US Corp0
    2014-01-30NAINo action indicatedCordis US Corp0
    2013-12-18NAINo action indicatedCordis US Corp0
    2013-12-18NAINo action indicatedCordis US Corp0
    2012-07-03NAINo action indicatedCordis US Corp0
    2011-02-16WLWarning LetterCordis LLC—
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