Boston Scientific LUX-Dx II Arrhythmia Detector
Boston Scientific is recalling LUX-Dx II arrhythmia detectors due to a software error that prevents proper monitoring and data collection.
Contact your healthcare provider to verify if your device is affected and to determine if a manual update or clinical follow-up is required to ensure proper monitoring.
Why it was recalled
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.
How to identify it
UPC 00802526620713
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Where it was sold
Distributed in US.
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · last updated 2026-05-25 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification