Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
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.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
- Sold in
- Nationwide
- Made for
- Adults
This recall covers 3 products — see all of them.
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 4100 Hamline Ave N, N/A, Saint Paul, MN, United States
- Classification
- Class II
- Recall number
- Z-3082-2026
In the FDA's words
- Description
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7) 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. UDI-DI: 00802526613883 Distribution: Worldwide - US Nationwide distribution. Affected quantity: N/A
- Hazard
- 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.
3 products in this recall
Boston Scientific LUX-Dx monitor software recalled for alert delay
Boston Scientific is recalling server software that supports its LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors. The recall covers three products, one for each region: US, EU, and ANZ. The software can delay notifications of AF Burden Alerts, which are alerts about atrial fibrillation, and a delayed alert may delay clinical review or treatment. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)Z-3081-2026 · N/A
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7) (this page)Z-3082-2026 · N/A
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)Z-3083-2026 · N/A
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ModerateFDAAug 26, 2026