Boston Scientific recalls LUX-Dx II Plus arrhythmia monitors with specific software versions that may not correctly track heart rhythm issues, requiring patient monitoring adjustments.
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 certain LUX-Dx II Plus arrhythmia monitors that may not properly track heart rhythm problems. This could lead to missed health warnings for patients with heart conditions.
The device may not collect critical heart rhythm data like PVC Burden or Bradyarrhythmia, and its programming screens show conflicting information about monitoring settings. This could mean important health warnings are missed.
Patients using the LUX-Dx II Plus model M312 with specific software versions (Europe or Australia/New Zealand) who were upgraded from older models. Those with heart conditions are most at risk.
Check for the model M312 with SERVER SW LATITUDE DRAGON EU (Europe) or AU (Australia/New Zealand) software versions. Look for specific serial numbers listed in the recall notice or UDI-DI codes provided.
Review your device's serial number and software version to confirm if it matches the recalled items listed in the official notice.
The device may not correctly track heart rhythm data like PVC Burden or Bradyarrhythmia, and its programming screens show conflicting monitoring settings.
No, the recall does not require immediate stoppage. Patients should check their device details to see if it's affected.
Check your device's serial number and software version against the list provided in the official recall notice to determine if it's affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2049-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2049-2026 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.
