ProductGuru Recalls

Official recall record

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

US FDA — Medical Devices · 2026-03-30 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Alert date
2026-03-30
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
00802526620713
Brand on record
Boston Scientific Corporation

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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