FDAClass II · Medical device · Recalled May 13, 2026

LUX-DX II recall — Boston Scientific Corporation

Hazard: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2048-2026
Brand: Boston Scientific
Classification: Class II
Units affected: 2 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

Affected products

LUX-DX II

Companies & origin

Recalling firm location: Saint Paul, MN, United States
Firm address: 4100 Hamline Ave N, 55112-5700

Identifying details (verbatim from the notice)

Product codes / lots: LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787
Distribution: Worldwide distribution - US Nationwide and the country of Belgium.
Firm notified the public via: Letter
FDA event ID: 98679
Recall initiated: March 30, 2026
FDA classified: May 1, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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