Recall archive / FDA device enforcement
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 — FDA record Z-2048-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 30, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 2 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2048-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the country of Belgium.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 13, 2026
- Recall initiation date
- Mar 30, 2026
- Center classification date
- May 1, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.