Recall Z-3082-2026— Boston Scientific Corporation

Name: FDA recall Z-3082-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-06

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-08-06. It names one FDA 510(k) clearance: K231328. 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: 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: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-08-06
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp·cleared 2023-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.