Class 2 Device Recall LUXDx, LUXDx II, LUXDx II

• Date Initiated by Firm: August 06, 2026
• Date Posted: September 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3081-2026
• Recall Event ID: 99524
• 510(K)Number: K231328
• Product Classification: Recorder, event, implantable cardiac, (with arrhythmia detection) - Product Code MXD
• Product: 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: UDI-DI: 00802526613838
• FEI Number: 2124215
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: 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
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MXD