Boston Scientific LUX-Dx cardiac monitor server software recalled for delayed alert notifications
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.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- 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.
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 US, Model Number 7260, All Versions (Current 7.8)
- 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-3081-2026
In the FDA's words
- Description
- 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) 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: 00802526613838 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) (this page)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)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