LUX-Dx Insertable Cardiac Monitor System Software
Boston Scientific recalls LUX-Dx ICM server software (Model 7260) over delayed AF Burden Alerts.
Contact Boston Scientific for software update instructions. Do not delay seeking medical care if you experience symptoms of atrial fibrillation.
Why it was recalled
Boston Scientific is recalling the LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System server software (Model 7260, all versions) due to a potential delay in AF Burden Alert notification, which may delay clinical evaluation or therapeutic intervention of atrial arrhythmia.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS
| Product | UDI-DI |
|---|---|
| EU, Model Number 7246, All Versions (Current 7.7) | 00802526613883 |
| ANZ, Model Number 7248, All Versions (Current 7.7) | 00802526613852 |
| US, Model Number 7260, All Versions (Current 7.8) | 00802526613838 |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Software Defect recalls
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification