Moderate riskFDA DeviceSep 9, 2026Class II

Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification

Boston Scientific's server software for LUX-Dx insertable cardiac monitors may delay notifications of atrial fibrillation (AF) burden alerts. This delay could postpone a doctor's evaluation or treatment of an irregular heart rhythm.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

Contact your cardiologist or device clinic if you have a LUX-Dx insertable cardiac monitor
Do not discontinue monitoring or stop taking prescribed heart medications
Your healthcare provider will advise on any software updates or monitoring adjustments needed

Official notice ↗

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 ANZ, Model Number 7248, 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-3083-2026

In the FDA's words

Description: 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) 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: 00802526613852 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)
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) (this page)
Z-3083-2026 · N/A