Device recall

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)

FDA recall source

Recall number

Z-3083-2026

Event id

99524

Status

Ongoing

FDA classification

Class II

Recalling firm

Boston Scientific Corporation

Report date

Sep 9, 2026

Posted

Sep 2, 2026

Initiated

Aug 6, 2026

Center classification date

Sep 2, 2026

Product code

MXD

Device type

Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

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.

Root cause

Software design

Quantity

N/A

Code info

UDI-DI: 00802526613852

Distribution

Worldwide - US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K231328

Location

Saint Paul, MN, United States