BEUDAMED
    FDA Enforcement Class II Terminated

    Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.

    Recall: Z-1249-2016 · Reported April 6, 2016

    Enforcement

    Recall Number
    Z-1249-2016
    Event ID
    73494
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 6, 2016
    Initiation Date
    February 23, 2016
    Classification Date
    March 25, 2016
    Termination Date
    September 25, 2017
    Address
    8200 Coral Sea St Ne, N/A, Saint Paul, MN, 55112-4391, United States

    Description

    Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.

    Reason

    Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal

    Code Info

    All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.

    Distribution

    Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates and United Kingdom.

    Quantity

    189,009