FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: 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)
- Recall number
- Z-3082-2026
- Recalling firm
- Boston Scientific Corporation
- 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)
- Status
- Open, Classified
- Initiated
- 2026-08-06
- Posted
- 2026-09-02
- Terminated
- not on file
- 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.
- 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
- Quantity
- not on file
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 00802526613883
- 510(k) numbers
- ["K231328"]
- PMA numbers
- not on file
- Product code
- MXD
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28