BEUDAMED
    FDA Enforcement Class II Terminated

    Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

    Recall: Z-0391-2022 · Reported December 22, 2021

    Enforcement

    Recall Number
    Z-0391-2022
    Event ID
    89054
    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
    December 22, 2021
    Initiation Date
    November 8, 2021
    Classification Date
    December 16, 2021
    Termination Date
    May 4, 2026
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391, United States

    Description

    Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

    Reason

    The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."

    Code Info

    Astra XT DR implantable pulse generator, Product Number/CFN X2DR01, UDI 00763000108953, Serial Numbers: RNH655287S, RNH648107S, RNH645452S, RNH634608S, RNH642593S, RNH638740S, RNH635040S, RNH636809S, RNH633755S UDI 00643169634671, Serial Numbers: RNH612514S

    Distribution

    US, Canada, Northern Mariana Islands

    Quantity

    10 Medical Device Cards