Z-3081-2026Class II

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number...

Name: Z-3081-2026 LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number...
Creator: Boston Scientific Corporation
Published: 2026-08-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-08-06 / Open, Classified / root cause: software

FDA source

Boston Scientific Corporation began a recall of 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) on 2026-08-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-3081-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-06
Posted: 2026-09-02
Recalling firm: Boston Scientific Corporation
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)
Product code: MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
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.
Root cause tag: software
FDA root 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.
Product codes and lots: UDI-DI: 00802526613838

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3081-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3081-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02
Z-3082-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02
Z-3083-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02

Product code MXD

K231328Class IILUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp / cleared 2023-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)