United StatesThe LUX‑Dx, LUX‑Dx II and LUX‑Dx II+ Insertable Cardiac Monitor Systems using SERVER SW LAT CLARITY DS (Model 7260, all versions current 7.8; Model 7246, all versions current 7.7 for EU; Model 7248, all versions current 7.7 for ANZ) are affected. The devices were recalled because the server software can potentially delay AF Burden Alert notifications, which may delay clinical evaluation or therapeutic intervention for an atrial arrhythmia.
What's being recalled
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)
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)
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)
Recalling firm: Boston Scientific Corporation, Saint Paul, MN, United States.
How to identify it
UDI-DI: 00802526613838 UDI-DI: 00802526613883 UDI-DI: 00802526613852
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada