BEUDAMED
    FDA Enforcement Class I Ongoing

    Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

    Recall: Z-1302-2024 · Reported April 3, 2024

    Enforcement

    Recall Number
    Z-1302-2024
    Event ID
    94082
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2024
    Initiation Date
    February 12, 2024
    Classification Date
    March 26, 2024
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

    Reason

    Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).

    Code Info

    GTIN 08714729992684, Batch Numbers: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976

    Distribution

    Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan

    Quantity

    461 devices