Class IIDeviceOngoing

Boston Scientific Corporation

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)

Reason for recall

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.

Details

Recall number: Z-3081-2026
Event ID: 99524
Recall initiated: Aug 6, 2026
Classified: Sep 2, 2026
Reported: Sep 9, 2026
Quantity: N/A
Distribution: Worldwide - US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm notification: N/A
Firm location: Saint Paul, MN, United States
Lot / code info: UDI-DI: 00802526613838