BEUDAMED
    FDA Enforcement Class II Terminated

    Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application

    Recall: Z-0319-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0319-2021
    Event ID
    86534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 11, 2020
    Initiation Date
    September 22, 2020
    Classification Date
    October 31, 2020
    Termination Date
    September 4, 2024
    Address
    4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application

    Reason

    There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.

    Code Info

    Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751

    Distribution

    Distributed in US - AR, FL, IL, and TX

    Quantity

    8 devices