Boston Scientific LUX-Dx cardiac monitor server software recalled for delayed alert notifications
What this means
Boston Scientific's server software that supports LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors may delay notifications of abnormal heart rhythm (atrial fibrillation) alerts. This delay could postpone a patient's clinical evaluation or treatment of an irregular heartbeat.
- Contact Boston Scientific or your healthcare provider if you have one of these devices.
- Do not stop using or remove your device without medical guidance.
- Ask your provider about any software updates available for your device's monitoring system.
The agency's original wording
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3081-2026More Boston Scientific recalls
- FDA-Device2026-09-09Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
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