LUX-DX II Arrhythmia Detector Monitoring Function Data Collection Issue
Boston Scientific is recalling the LUX-DX II Model M302 and M312 arrhythmia detectors because some upgraded devices are not collecting PVC Burden data or monitoring for Bradyarrhythmia and Pause, with conflicting information shown in programming screens.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source is an FDA Class II recall involving a cardiac monitoring device. The hazard involves loss of critical monitoring functions (PVC Burden, Bradyarrhythmia, Pause detection) that could delay detection of serious arrhythmias, creating a risk of harm to cardiac patients. No reported illnesses or injuries are stated in the source text, so the score is 3 per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling the LUX-DX II Arrhythmia Detector and Alarm, Model M302 and M312, with SERVER SW LATITUDE DRAGON US software. For some patients upgraded from a LUX-Dx M301 device to a new M302 or M312, the device is not collecting PVC Burden data (affecting both M302 and M312 models) or monitoring for Bradyarrhythmia and Pause (M312 only).
In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens display conflicting information. The screens indicate that monitoring is enabled for these features in one location but disabled in another, creating discrepancies in the device settings. This can prevent proper cardiac monitoring and data collection.
Two units have been identified and distributed worldwide, including in the United States and Belgium. Patients who have undergone an upgrade from a LUX-Dx M301 to a new M302 or M312 device may be affected. Patients should contact Boston Scientific or their healthcare provider to determine if their device requires evaluation or reprogramming.
The recalled product
- Product
- LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
- Manufacturer
- Boston Scientific Corporation
- Hazard
- monitoring-function-failure
- data-collection-failure
- software-discrepancy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- LUX-DX II UDI-DI: 00802526620713
- SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US
- Serial Number: 104263 109787
Distribution
Distributed nationwide across the United States.