BEUDAMED
    FDA Recall Terminated

    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

    Recall: Z-0079-2018 · Initiated October 4, 2017

    Recall

    Recall Number
    Z-0079-2018
    Event Number
    78323
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 4, 2017
    Terminated
    October 15, 2019
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

    Reason

    The devices have an incorrect firmware configuration.

    Action

    The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.

    Distribution

    The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

    Quantity

    4 devices