BEUDAMED
    FDA Enforcement Class II Terminated

    Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666

    Recall: Z-2143-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2143-2020
    Event ID
    85477
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spectranetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    March 31, 2020
    Classification Date
    May 28, 2020
    Termination Date
    October 31, 2022
    Address
    9965 Federal Dr, N/A, Colorado Springs, CO, 80921-3822, United States

    Description

    Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666

    Reason

    There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.

    Code Info

    All lots

    Distribution

    US: Nationwide OUS: Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, The Netherlands, and the United Kingdom of Great Britain and Northern Ireland

    Quantity

    N/A