⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Boston Scientific Corporation: 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)

Medical DevicesSource: FDA (device) · Date: 2026-09-09

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Boston Scientific Corporation
Product
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)
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution.
Recall initiated
2026-08-06
Code info
UDI-DI: 00802526613883
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Saint Paul
State
MN
Country
United States
Event id
99524
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