FDAFDA · Food and drugs·Recall number Z-3082-2026
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)
Published September 9, 2026 · Recall initiated: August 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- UDI-DI: 00802526613883
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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