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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
2022-03-31Z-0503-2024Class IIOpen, ClassifiedIncorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedureDistribution: Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND169 unitsclearance family
2022-03-31Z-0504-2024Class IIOpen, ClassifiedIncorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedureDistribution: Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND90 unitscode info di
Regulatory clearances

    Predicate lineage

    K013972

    Cited as predicate by: K143415

    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
    2024-02-01VAIVoluntary action indicatedCooperSurgical, Inc.0
    2023-05-16NAINo action indicatedCooperSurgical, Inc.0
    2023-05-16NAINo action indicatedCooperSurgical, Inc.0
    2023-04-27VAIVoluntary action indicatedLone Star Medical Products, Inc.5
    2022-12-15NAINo action indicatedLeisegang Feinmechanick-Optik GmbH0
    2021-07-15VAIVoluntary action indicatedCooperSurgical, Inc.4
    2021-07-15VAIVoluntary action indicatedCooperSurgical, Inc.4
    2019-08-01NAINo action indicatedCooperSurgical, Inc.2
    2018-05-02NAINo action indicatedLone Star Medical Products, Inc.0
    2017-12-07NAINo action indicatedCooperSurgical, Inc.0
    2017-12-07NAINo action indicatedCooperSurgical, Inc.0
    2017-05-04NAINo action indicatedLone Star Medical Products, Inc.0
    2016-03-31NAINo action indicatedCooperSurgical, Inc.0
    2016-03-31NAINo action indicatedCooperSurgical, Inc.0
    2015-12-10NAINo action indicatedLeisegang Feinmechanick-Optik GmbH0
    2015-06-09WLWarning LetterCooperSurgical, Inc.—
    2015-06-09WLWarning LetterCooperSurgical, Inc.—
    2014-12-17OAIOfficial action indicatedCooperSurgical, Inc.8
    2014-12-17OAIOfficial action indicatedCooperSurgical, Inc.8
    2014-12-01NAINo action indicatedCooperSurgical, Inc.0
    2014-12-01NAINo action indicatedCooperSurgical, Inc.0
    2014-09-23VAIVoluntary action indicatedLone Star Medical Products, Inc.0
    2013-04-25WLWarning LetterLone Star Medical Products, Inc.—
    2012-07-11WLWarning LetterLeisegang Feinmechanick-Optik GmbH—
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