BEUDAMED
    FDA Enforcement Class I Terminated

    Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

    Recall: Z-3106-2017 · Reported October 4, 2017

    Enforcement

    Recall Number
    Z-3106-2017
    Event ID
    77934
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spectranetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 4, 2017
    Initiation Date
    August 7, 2017
    Classification Date
    September 22, 2017
    Termination Date
    April 14, 2020
    Address
    9965 Federal Drive, N/A, Colorado Springs, CO, 80921-3617, United States

    Description

    Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

    Reason

    Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.

    Code Info

    Model Number 590-001, Lots FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN47D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A. Additional lots: FMN17H03A, FMN17H04A, FMN17H05A, FMN17H10A, FMN17H12A, FMN17H15A, FMN17H17A, FMN17H29A, FMN17J28A, FMN17K02A.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and United Kingdom.

    Quantity

    2,356 units