FDA Medical devices recall ·
LUX-DX II, Arrythmia detector and alarm, Model M302… recall
- Recall number
- Z-2048-2026
- Date
- (initiated March 30, 2026)
- Company / brand
- Boston Scientific Corporation
4100 Hamline Ave N, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787
Distribution
Worldwide distribution - US Nationwide and the country of Belgium.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2048-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.