FDA DevicesClass II
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRA...
Published: May 13, 2026Recall ID: Z-2048-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Additional Source Details
| Field | Value |
|---|---|
| City | Saint Paul |
| State | MN |
| Event id | 98679 |
| Address 1 | 4100 Hamline Ave N |
| Code info | LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787 |
| Postal code | 55112-5700 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 2 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260330 |
| Initial firm notification | Letter |
| Center classification date | 20260501 |
Overview
- Recalling FirmBoston Scientific Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the country of Belgium.