Boston Scientific recalls LUX-DX II arrhythmia detectors with specific software versions that may not monitor heart rhythms properly, risking missed health alerts.
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.
Boston Scientific is recalling LUX-DX II arrhythmia detectors with certain software versions that may not monitor heart rhythms correctly. This could lead to missed health alerts for patients with heart conditions.
The device may not collect critical heart rhythm data or monitor for certain heart conditions after software updates. This can cause missing health alerts that might be life-threatening.
Patients using the LUX-DX II arrhythmia detector with the specified software version are affected. Those with heart conditions are most at risk.
Check for the model number M302 with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5. The device has a unique identifier starting with 00802526620713.
Look for the software version on the device's display or in the user manual.
The device may not monitor heart rhythms properly after software updates, potentially missing critical health alerts.
The official recall notice does not specify a remedy or action steps for affected devices.
The recall indicates potential issues with monitoring heart rhythms, so it is not recommended to use without checking the software version.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2048-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2048-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
