Boston Scientific LUX-DX II Arrhythmia Detector
Boston Scientific recalls LUX-DX II Arrhythmia Detector (M302) with LATITUDE DRAGON US Server (6460) over missing PVC Burden and Bradyarrhythmia monitoring.
Contact Boston Scientific or your healthcare provider to determine if your device is affected and to schedule a software update or device replacement. Do not attempt to modify the device yourself.
Why it was recalled
Boston Scientific is recalling the LUX-DX II Arrhythmia Detector and Alarm (Model M302) when used with the LATITUDE DRAGON US Server (Model 6460, Version 7.5) because for some patients upgraded from a LUX-Dx M301 device, the new ICM device is not collecting PVC Burden data (M302 and M312) or monitoring for Bradyarrhythmia and Pause (M312 only). Additionally, the LATITUDE Clarity programming screens show discrepant information, indicating monitoring is enabled in one location but not another.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 | Z-2048-2026 | 00802526620713 |
| 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 | Z-2049-2026 | 00802526620706, 00802526623707, 00802526613821, 00802526613814 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification