FDA-Device2026-09-09Class IIPROCESSING DEFECT
Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification
What this means
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.
- 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
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
N/A
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3083-2026More Boston Scientific recalls
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
- 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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