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Recall Observatory FDA recall evidence

Device product

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

Z-2048-2026

March 30, 2026

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 98679
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2048-2026

Official wording

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.

Code information: LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787

Distribution pattern: Worldwide distribution - US Nationwide and the country of Belgium.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.