BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated March 4, 2019

    Recall

    Recall Number
    Z-1069-2019
    Event Number
    82319
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    OAE
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    March 4, 2019
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    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.

    Action

    The firm initiated the communication on 03/04/2019 by letter. Consignees are asked to review the communication to understand that Medtronic is adding current recommendations for reducing the potential for PNI. The IFU will be updated globally, including completing submissions and obtaining regulatory approvals, where prior approvals are required. This event involves OUS consignees only.

    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