BEUDAMED
    FDA Recall Open, Classified

    LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

    Recall: Z-2048-2026 · Initiated March 30, 2026

    Recall

    Recall Number
    Z-2048-2026
    Event Number
    98679
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    MXD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 30, 2026
    Posted
    May 1, 2026
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

    Reason

    For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

    Action

    An IMPORTANT Medical Device Correction notification letter dated 3/30/26 was sent to customers. Recommendations As noted previously, Boston Scientific released an update to LATITUDE Clarity on March 27, 2026 to correct this programming discrepancy. Devices impacted by this issue will be automatically corrected to the clinician assigned programming once the device successfully reconnects with LATITUDE Clarity. To confirm updated programming settings have been applied to the impacted M302/M312 device: " Navigate to the patient s profile on LATITUDE Clarity; " Verify that the last connection to the device occurred after March 27, 2026. If not, the patient will need to reconnect their mobile monitor; " Check device programming under Counters and Settings and verify that Brady, Pause, and PVC Burden are set as desired; " Complete and return the enclosed Acknowledgment Form per the instructions. Boston Scientific s RhythmCARE" Support Team is available to assist HCPs with resolving this programming discrepancy, confirming programmed settings, or assisting with reconnecting a patient, either remotely or in-clinic. Additional Information Patient safety remains Boston Scientific s highest priority. We recognize the impact of this device behavior on both you and your patients, and we are committed to transparent communication with physicians and other HCPs to ensure you have relevant information for managing your patients. If you have additional questions regarding the information described above or would like to report a clinical event, please contact the Boston Scientific RhythmCARE Support team. Adverse events may also be reported directly to the FDA s MedWatch Adverse Event Reporting program. United States RhythmCARE Support 1.800.CARDIAC (227.3422) [email protected]

    Distribution

    Worldwide distribution - US Nationwide and the country of Belgium.

    Quantity

    2 units