LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
Class II
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Belgium.
- State
- MN
- Status
- Ongoing
- Recall number
- Z-2049-2026
- Recall initiated
- March 30, 2026
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