Boston Scientific Corporation: Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

Recall Summary Boston Scientific is recalling certain implantable cardiac monitoring devices (LUX-DX II models M302 and M312) that were upgraded from older M301 models. In some cases, these devices stopped collecting data on irregular heartbeats and heart pauses, and the programming system showed conflicting information about whether monitoring was turned on or off. The recall affects devices distributed nationwide in the US and in Belgium.

Recalling firm: Boston Scientific Corporation
Product: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
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.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-03-30
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide distribution - US Nationwide and the country of Belgium.

Recall details on Nibble Recalls: https://trynibble.app/recalls/ace31cbf-bb6b-470e-97d0-cee62f9cac6d