BEUDAMED
    FDA Enforcement Class I Terminated

    ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

    Recall: Z-2073-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2073-2019
    Event ID
    83252
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    August 14, 2019
    Initiation Date
    June 20, 2019
    Classification Date
    August 2, 2019
    Termination Date
    April 3, 2024
    Address
    15900 Valley View Ct, N/A, Sylmar, CA, 91342-3577, United States

    Description

    ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

    Reason

    Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

    Code Info

    Serial Number: 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 1282609, 1282622, 1282625, 1282638, 1282641, 1282648, 9829389, 9831310, 9831509, 9831515, 9831516

    Distribution

    Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO

    Quantity

    21