BEUDAMED
    FDA Enforcement Class II Terminated

    LINQ II Insertable Cardiac Monitor

    Recall: Z-0782-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0782-2022
    Event ID
    89469
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2022
    Initiation Date
    January 18, 2022
    Classification Date
    March 11, 2022
    Termination Date
    May 4, 2026
    Address
    8200 Coral Sea St Ne, N/A, Mounds View, MN, 55112-4391, United States

    Description

    LINQ II Insertable Cardiac Monitor

    Reason

    Devices may lose functionality due to susceptibility to moisture ingress.

    Code Info

    8 impacted devices with the following Serial number and GTIN 1) Serial RLB035341G (GTIN 00763000060374) 2) Serial RLB051224G (GTIN 00763000060374) 3) Serial RLB059666G (GTIN 00763000060374) 4) Serial RLB061064G (GTIN 00763000060374) 5) Serial RLB061812G (GTIN 00763000060381) 6) Serial RLB066367G (GTIN 00763000060374) 7) Serial RLB091638G (GTIN 00763000060374) 8) Serial RLB122769G (GTIN 00763000554002)

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.

    Quantity

    8 devices