BEUDAMED
    FDA Recall Open, Classified

    ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)

    Recall: Z-0824-2025 · Initiated December 12, 2024

    Recall

    Recall Number
    Z-0824-2025
    Event Number
    95969
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWP
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    December 12, 2024
    Posted
    January 10, 2025
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)

    Reason

    A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

    Action

    The firm sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2024. The letter describes the product, problem and actions to be taken. The customers were instructed to promptly identify patients, if device enters Safety Mode, perform emergent replacement for patients who are at risk for harm, during replacement of a device in Safety Mode pacing inhibition should be anticipated during electrocautery. General prophylactic replacement is not recommended; schedule device replacement promptly when the longevity remaining reaches four (4) years or if the longevity remaining is less than 4 years, perform system follow-ups in accordance with the instructions for use and update patients records with letter to maintain awareness for the remaining service life of the device. If you have any questions regarding this information or would like to report a clinical event, contact your Boston Scientific representative or Technical Services. Supplement March 26, 2025, High-Level Overview of Recall Strategy: on 03/26/2025, BSC notified only those implanting and following clinicians responsible for the newly identified active advisory devices. The letter sent to these clinicians will be the original December 12, 2024, Product Advisory letter, however, the March 2025 communication included a cover letter stating that new devices were identified that should have been initially categorized in the Advisory population.

    Distribution

    US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.

    Quantity

    156,329 units (59,937 US, 96,792 OUS) in total