BEUDAMED
    FDA Recall Terminated

    Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. The Belos VR-T is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.

    Recall: Z-0817-03 · Initiated March 21, 2003

    Recall

    Recall Number
    Z-0817-03
    Event Number
    26041
    Firm
    Biotronik Inc
    FEI Number
    1028232
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 21, 2003
    Posted
    May 14, 2003
    Terminated
    October 13, 2004
    Address
    6024 Jean Road, Lake Oswego, OR, 97035-5369

    Description

    Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. The Belos VR-T is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.

    Reason

    Potential extended charge time anomalies

    Action

    The firm issued a letter dated 3/21/03 via certified return receipt requested. The envelope and letter are flagged 'IMPORTANT: Patient Management Information'. The letter recommends that physicians schedule an immediate follow-up visit with each of their patients implanted with an affected Belos VR or VR-T ICD to evaluate the device charge times. The firm provided the doctors with the names of their patients.

    Distribution

    The firm distributed to physicians throughout the United States. The firm only distributes to US customers.

    Quantity

    49