- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787
- Units affected
- 2 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Belgium.
- Firm location
- Saint Paul, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2048-2026
- Recall initiated
- March 30, 2026
- FDA classification date
- May 1, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98679
- Last updated on HTM Vibe
- July 24, 2026