BEUDAMED
    FDA Enforcement Class II Terminated

    Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.

    Recall: Z-2335-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2335-2018
    Event ID
    80244
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 11, 2018
    Initiation Date
    April 16, 2018
    Classification Date
    June 29, 2018
    Termination Date
    February 4, 2021
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577, United States

    Description

    Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.

    Reason

    The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.

    Code Info

    Software Versions: 24.0.1 rev 1

    Distribution

    U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,

    Quantity

    0