Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
What this means
Boston Scientific's LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors may experience delays in sending AF Burden Alert notifications through their server software. These delayed alerts could postpone a patient's medical evaluation or treatment for irregular heart rhythms.
- If you have one of these devices, contact your cardiologist or device clinic to discuss the alert delay and confirm your monitoring plan.
- Do not stop using your device; continue regular monitoring appointments as scheduled.
- Watch for symptoms of irregular heartbeat (palpitations, shortness of breath, dizziness) and seek immediate care if you experience them.
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-3082-2026More 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 server software 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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