LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
Boston Scientific Corporation · There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed not…
Open FDA's page for this record- Cfres ID
- 221755
- Product res number
- Z-3083-2026
- Event date initiated
- 2026-08-06
- Event date posted
- 2026-09-02
- Recall status
- Open, Classified
- Res event number
- 99524
- Product code
- MXD
- Product description
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
- Code info
- UDI-DI: 00802526613852
- Firm FEI number
- 2124215
- Recalling firm
- Boston Scientific Corporation
- Address 1
- 4100 Hamline Ave N
- City
- Saint Paul
- State
- MN
- Postal code
- 55112-5700
- Root cause description
- Software design
- Distribution pattern
- Worldwide - US Nationwide distribution.
- 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.
- 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
- K numbers
- K231328
- Harmonized identifiers (openFDA)
- Device name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1025
- Device class
- 2
- K number
- K170628, K162855, K240693, K143503, K132960, K233320, K251221, K200444, K210608, K230375, K231328, K252593, K221962, K230553, K253516, K193473, K262735, K200795, K210484, K201865, K233562, K160809, K132649, K261074, K152995, K150614, K190548, K212008, K163460, K171514, K160689, K211304, K221856, K223630
- Registration number
- 9610139, 3009380063, 3008973940, 2017865, 9616693, 2124215, 3018094310, 3015544746, 2182208, 1028232, 3004185781, 9614453
- FEI number
- 3009380063, 3008973940, 3002618605, 2017865, 3002806500, 2124215, 3018094310, 3015544746, 2182208, 3002807576, 1028232, 3004185781