Company: Boston Scientific Corporation
Date of Enforcement Report: 9/2/2026
Class: II

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)

Recall Number:

Z-3082-2026

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Boston Scientific Corporation

VOLUME:

N/A

DISTRIBUTION:

Worldwide – US Nationwide distribution.