BEUDAMED
    FDA Recall Terminated

    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585

    Recall: Z-2074-2019 · Initiated June 20, 2019

    Recall

    Recall Number
    Z-2074-2019
    Event Number
    83252
    Firm
    St Jude Medical Inc.
    FEI Number
    2017865
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 20, 2019
    Posted
    August 2, 2019
    Terminated
    April 3, 2024
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585

    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.

    Action

    On 06/20/19, Sales Representatives visited impacted customer accounts to provide talking points that included the reason for recall and to retrieve affected devices. On 06/21/19, hand-delivery of Urgent Medical Device Recall Notices, to physicians supporting implanted patients, commenced. Customers were informed that there is no available option to verify the vulnerability status for implanted devices. Device explant and replacement are recommended. Customers were advised to: 1) Review the device model and serial numbers in the appendix of this letter to identify the impacted patients and return the acknowledgement form to your sales representative; and 2) Device explant and replacement are recommended. The recalling firm will work with customers to provide a replacement device. A copy of this letter is available on https://www.cardiovascular.abbott/us/en/hcp/resources/product/advisories.html. Customers with additional questions were encouraged to call 1-800-727-7846 (Opt3), 8:30am - 5:30pm Central Time, Monday thru Friday.

    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

    15