BEUDAMED
    FDA Enforcement Class II Terminated

    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly

    Recall: Z-1770-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1770-2020
    Event ID
    85197
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acutus Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    February 25, 2020
    Classification Date
    April 23, 2020
    Termination Date
    April 27, 2021
    Address
    2210 Faraday Ave Ste 100, N/A, Carlsbad, CA, 92008-7225, United States

    Description

    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly

    Reason

    It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.

    Code Info

    Affected Lot Numbers/Expiration Date: 19052006/ May 2020 19061318/ June 2020

    Distribution

    US: CA,SC, AZ OUS: None

    Quantity

    30 units