Boston Scientific Corporation recalls LUX-Dx
- Recalling company
- 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)
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 6, 2026
- Reported
- Sep 9, 2026
- Distribution
- Worldwide - US Nationwide distribution.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- UDI-DI: 00802526613883
- Company location
- Saint Paul, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3082-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3082-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.