BEUDAMED
    FDA Enforcement Class II Ongoing

    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

    Recall: Z-2405-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2405-2026
    Event ID
    98963
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    May 12, 2026
    Classification Date
    June 11, 2026
    Address
    15900 Valley View Ct, N/A, Sylmar, CA, 91342-3577, United States

    Description

    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

    Reason

    Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

    Code Info

    Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet

    Quantity

    11182 programs