BEUDAMED
    FDA Recall Terminated

    Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.

    Recall: Z-2492-2019 · Initiated August 6, 2019

    Recall

    Recall Number
    Z-2492-2019
    Event Number
    83547
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    PNJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 6, 2019
    Posted
    September 9, 2019
    Terminated
    June 26, 2023
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.

    Reason

    Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.

    Action

    In the US, beginning 06-Aug-2019, Medtronic Field Representatives are approved to provide the Instructions for Use Update Letter to physicians who have been trained to implant the Micra device as identified by Medtronic training records. Courtesy notifications to Risk Managers at accounts that have purchased Micra and Clinical Principal Investigators (PIs) at sites participating in clinical trials are also approved to be provided. The Instructions for Use Update letter will be sent via 2-day delivery beginning 12-Aug-2019 to the physicians and risk managers.

    Distribution

    Worldwide

    Quantity

    24521 units