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

Recall Summary Boston Scientific is recalling certain LUX-Dx II Plus cardiac monitoring devices (Model M312) and their associated server software used in the US, Belgium, Australia, and New Zealand. Some patients who received a new device to replace an older LUX-Dx M301 model are not having their heart rhythm data properly collected or monitored for certain dangerous conditions like abnormal heartbeats and pauses, even though the device's programming screens indicate monitoring is turned on. This discrepancy means some patients may not be receiving the cardiac monitoring they need.

Recalling firm: Boston Scientific Corporation
Product: 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
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/330ce443-e5e4-437e-a5f1-f999f53c4eb7