BEUDAMED
    FDA Enforcement Class III Ongoing

    Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.

    Recall: Z-1069-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1069-2019
    Event ID
    82319
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2019
    Initiation Date
    March 4, 2019
    Classification Date
    March 28, 2019
    Address
    8200 Coral Sea St Ne, N/A, Mounds View, MN, 55112-4391, United States

    Description

    Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.

    Reason

    The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

    Code Info

    UDI 00643169522572 All lot numbers distributed in the past eighteen (18) months and all newly manufactured without the updated IFU are affected until product with the updated Instruction for Use (IFU) is available.

    Distribution

    International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.

    Quantity

    2917 units