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LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor… recallZ-3081-2026 · Boston Scientific Corporation · initiated Aug 6, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

An Urgent Medical Device Correction dated August 2026 was sent to customers. Boston Scientific is notifying you of the potential for a delay in AF Burden Alert notification affecting the LATITUDE" Clarity server software which supports the LUX-Dx" family of ICMs. This delayed AF Burden Alert notification behavior by LATITUDE Clarity may occur if the Alert for AF Burden e Threshold is configured to ">0 hours per day" setting (a non-default configuration). The ICM is performing as intended with continued AF detection, data storage, and transmission of device data. Boston Scientific has received one complaint related to this delayed notification behavior by the LATITUDE Clarity System. No patient injuries or deaths have been reported. A server software update is planned to correct this behavior. Configuration Options for Atrial Alert Notifications: Atrial arrhythmia alert notification preferences may vary, and AF configurations may be set for individual patients and/or group settings. Until updated server software is available, consider the following options: Change Threshold for AF Burden Alert Setting Enable AF Events Alert with Minimum Duration If Unchanged, Potential Delay in AF Burden Alert Notification " Boston Scientific does not recommend replacement of the implanted ICM. " Please share this notification with all HCPs within your organization who manage patients using the LUXDx ICM and LATITUDE Clarity System. Mitigation. The LATITUDE Clarity system is designed to detect atrial fibrillation through two independent mechanisms: AF Burden and AF Event Alerts. Until a software update to the LATITUDE Clarity server software is available, configuring AF Events or changing AF Burden Alerts settings can mitigate delays in full device interrogation and enable the LATITUDE Clarity system to display alert notification as intended. Additional Information. The Regulatory Authority of your country has been informed of this communication. Adverse events should be reported

Recall details

Recall number
Z-3081-2026
Status
Open, Classified
Initiated by the company
Aug 6, 2026
Posted by the FDA
Sep 2, 2026
Recalling firm
Boston Scientific Corporation
Product code
MXD
FDA submissions
K231328
Distribution
Worldwide - US Nationwide distribution.

Product description

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)

Code information (models, lots, serial numbers)

UDI-DI: 00802526613838

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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