Boston Scientific Corporation is recalling 150 LUX-Dx II and LUX-Dx II Plus Insertable Cardiac Monitor (ICM) devices because they may fail to monitor for certain heart rhythm issues. For patients upgraded from older models, the new devices might not collect Premature Ventricular Contraction (PVC) data or monitor for slow heart rates (bradyarrhythmia) and heart pauses. Additionally, the programming software may incorrectly show these features as enabled when they are actually inactive.
If these heart monitoring features are not functioning, serious heart rhythm disturbances like slow heart rates or pauses may go undetected, preventing necessary medical intervention. While the programming screen may indicate monitoring is active, the device is not actually recording the data or triggering necessary alarms.
Affected when upgraded from a LUX-Dx M301 device.
Affected when upgraded from a LUX-Dx M301 device.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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