BEUDAMED
    FDA Recall Terminated

    Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02

    Recall: Z-0046-05 · Initiated September 27, 2004

    Recall

    Recall Number
    Z-0046-05
    Event Number
    30209
    Firm
    Advanced Bionics
    FEI Number
    1000220815
    Product Code
    MCM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2004
    Posted
    October 23, 2004
    Terminated
    July 13, 2005
    Address
    12750 San Fernando Rd, Sylmar, CA, 91342-3728

    Description

    Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02

    Reason

    All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.

    Action

    Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.

    Distribution

    U.S. and Canada and France

    Quantity

    46 units