Boston Scientific Corporation recalls LUX-DX II
- Recalling company
- Boston Scientific Corporation
- Product
- LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
- Reason
- For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 30, 2026
- Reported
- May 13, 2026
- Distribution
- Worldwide distribution - US Nationwide and the country of Belgium.
- Status
- Ongoing
- Quantity
- 2 units
- Lot / codes
- LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787
- Company location
- Saint Paul, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2048-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2048-2026 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.