BEUDAMED
    FDA Recall Open, Classified

    Model Number L101, ESSENTIO DR SL Pacemaker

    Recall: Z-0093-2026 · Initiated August 20, 2025

    Recall

    Recall Number
    Z-0093-2026
    Event Number
    97467
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    August 20, 2025
    Posted
    October 10, 2025
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Model Number L101, ESSENTIO DR SL Pacemaker

    Reason

    Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

    Action

    Boston Scientific issued an "Urgent Medical Device Correction" notice to its customers on 08/18/2025 via letter. The notice provides an update to the December 2024 customer communication regarding the potential for the ACCOLADE family of pacemakers to initiate Safety Mode due to a high battery impedance state and contains recommendations timely upgrade of pacemaker software to prevent the occurrence of Safety Mode in an ambulatory setting. On 09/05/2025 an update to the 08/18/2025 notice (via letter), superseding the prior notice to address two unintended behaviors associated with the Model 3869 v2.04 software (designed to prevent potential initiation of Safety Mode due to a high battery impedance condition). The behaviors are: 1. Incomplete disablement of wandless automatic telemetry after detecting a high battery impedance condition. If an ACCOLADE family device with an elevated battery impedance induced Code-1003 remains in service, the software s new telemetry activated battery test is designed to continue assessing battery impedance and disable all wandless telemetry operation before high impedance is achieved and device resets can initiate Safety Mode. 2. Potential for the software s new daily battery test to misinterpret measurements in the presence of a magnet, initiating a false positive response that results in disablement of wandless telemetry sessions. For patients monitored via LATITUDE, this will trigger an alert message indicating an erroneous explant indicator (e.g., explant indicator was reached January 1, 2000) if the device had not previously reached replacement indication, stating that LATITUDE is no longer available, and prompting to contact Technical Services. Patients were notified regarding battery performance. Advisory is published at www.BostonScientific.com/advisory. If you have any questions, contact US Technical Services at 1.800.CARDIAC (227.3422) or email to: [email protected].

    Distribution

    Worldwide

    Quantity

    22,714 units