BEUDAMED
    FDA Recall Open, Classified

    Merlin PCS 3650 programmer Model 3330 software

    Recall: Z-0964-2022 · Initiated March 10, 2022

    Recall

    Recall Number
    Z-0964-2022
    Event Number
    89816
    Firm
    St. Jude Medical, Cardiac Rhythm Management Division
    FEI Number
    2017865
    Product Code
    OSR
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 10, 2022
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Merlin PCS 3650 programmer Model 3330 software

    Reason

    Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

    Action

    The Recalling firm is sending an "Urgent Medical Device Correction" Letter to physicians and healthcare professionals informing them of a programmer software anomaly that may be encountered when executing a pacing capture Decrement Test in-clinic on a Gallant, or Entrant device using a Merlin Patient Care System (PCS) programmer. If a user presses the Hold to Test button and decides to stop testing by releasing the button prior to the first voltage decrement (within a narrow time window approximately 2.5 seconds after test initiation), the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters. Customers instructions/recommendations regarding patient management: The Recalling Firm has developed updated software (v25.4X rev 1 or higher) which will correct this issue. A Recalling Firm Representative will be upgrading the programmer software beginning in March 2022. For any questions, contact Abbott Technical Support at 1-800-722-3774.

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentina, Australia, AUSTRIA, Bahrain, Bangladesh, BELGIUM, Brazil, Bulgaria, Canada, Chile, COLOMBIA, COSTA RICA, Cyprus, Czech republic, DENMARK, ECUADOR, Egypt, Estonia, Faroe Islands, FINLAND, FRANCE, French Guiana, French Polynesia, GERMANY, Greece, Greenland, Guadeloupe, HUNGARY, Iceland, India, IRELAND, ITALY, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, LITHUANIA, Luxembourg, Malaysia, Malta, Martinque, Mayotte, MEXICO, Nepal, NETHERLANDS, New Caledonia, New Zealand, NORWAY, Oman, Pakistan, Palestine, POLAND, PORTUGAL, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Srilanka, SWEDEN, SWITZERLAND, Thailand, UAE, and UNITED KINGDOM.

    Quantity

    30,069 devices with software