LUX-Dx II Plus Arrythmia Detector Software Monitoring Feature Failure
Boston Scientific's LUX-Dx II Plus implantable cardiac monitors may fail to collect PVC Burden data or monitor for abnormal heart rhythms in some upgraded devices, creating potential gaps in patient monitoring.
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: This is an FDA Class II recall involving a medical device with a serious monitoring defect that could result in missed detection of dangerous cardiac arrhythmias in implantable monitors. No illnesses or injuries are reported in the source text, but the risk of harm from undetected cardiac events is significant, meeting the High severity threshold for risk-of-harm products without reported adverse outcomes.
Plain-English summary
Boston Scientific Corporation is recalling certain LUX-Dx II Plus arrythmia detectors (Model M312) and their associated server software. The devices affected are units that were implanted in patients upgraded from earlier LUX-Dx M301 models.
For some patients who received these new devices, the implantable cardiac monitor is not collecting PVC Burden data or monitoring for Bradyarrhythmia and Pause events. Additionally, the LATITUDE Clarity programming screens show conflicting information, indicating that these monitoring features appear enabled in one location but disabled in another, which may lead clinicians to believe monitoring is active when it is not.
A total of 148 units have been distributed worldwide, including throughout the US and in Belgium. The affected devices carry specific UDI identifiers and serial numbers documented by the FDA.
Patients with these devices should contact Boston Scientific or their healthcare provider immediately to determine whether their device is affected and to discuss appropriate monitoring and potential remediation options.
The recalled product
- Product
- LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- monitoring-failure
- software-defect
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 (4)
- LUX-Dx II Plus UDI-DI: 00802526620706 (US)
- 00802526623707 (EU/AU)
- SERVER SW LATITUDE DRAGON EU UDI-DI: 00802526613821
- SERVER SW LATITUDE DRAGON AU UDI-DI: 00802526613814
Distribution
Distributed nationwide across the United States.