BEUDAMED
    FDA Recall Terminated

    Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330

    Recall: Z-1351-2020 · Initiated January 22, 2020

    Recall

    Recall Number
    Z-1351-2020
    Event Number
    84849
    Firm
    St Jude Medical, Cardiac Rhythm Management Division
    FEI Number
    2017865
    Product Code
    NVZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 22, 2020
    Terminated
    December 17, 2020
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330

    Reason

    Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.

    Action

    Starting on 01/22/20, Important Medical Device Correction notices were hand delivered by the recalling firm's sales representatives. Physicians were informed that the recalling firm developed a software patch for programmers which restores wireless RF communication capability in affected devices. Device explant is not required for the update. The recalling firm will assist in updating programmer software and restoring wireless RF communication for affected devices. Correction notices recommend working with firm representatives to help correct affected devices during the patient's next regularly scheduled visit. Physicians were asked to complete and return the Acknowledgement Forms and to retain the correction notice. Customers with additional questions were encouraged to call Technical Support at 1-800-722-3774.

    Distribution

    U.S.: WV, MS, TX, DE, OH, AZ, MI, NC, KY, WA, NY, CA, IN, MO, MD, NJ, FL, PA, OK. O.U.S.: United Kingdom, Turkey, Sweden, Spain, Portugal, Poland, Philippines, Pakistan, Norway, New Zealand, Netherlands, Japan, Italy, Hong Kong, Greece, Germany, France, Finland, Denmark, Canada, Belgium, Austria, Australia

    Quantity

    256