Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alert notifications, which may delay clinical evaluation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involves a medical device where a software delay could postpone clinical evaluation or therapeutic intervention for an atrial arrhythmia. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System server software (Model Number 7248, All Versions, Current 7.7). The recall involves the SERVER SW LAT CLARITY DS ANZ software component.
The recall is issued because there is a potential for a delay in Atrial Fibrillation (AF) Burden Alert notifications. This delay may affect the server software supporting the Insertable Cardiac Monitors (ICMs). A delayed notification of an AF Burden Alert may result in a delay in the clinical evaluation or therapeutic intervention of an atrial arrhythmia.
The affected products were distributed worldwide and nationwide in the United States. The source text does not specify the number of units affected or report any specific injuries or illnesses. Consumers and healthcare providers should consult the official FDA recall notice for specific instructions on how to proceed.
The recalled product
- Product
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Monitor
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 (1)
- UDI-DI: 00802526613852
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · delayed notification
See all →- HighZio AT Ambulatory ECG Monitoring System Documentation Labeling Update
FDA (Devices) · 2022-11-16
Similar recalls
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighLUX-Dx II Plus Arrythmia Detector Software Monitoring Feature Failure
FDA (Devices) · 2026-05-13
- HighLUX-DX II Arrhythmia Detector Monitoring Function Data Collection Issue
FDA (Devices) · 2026-05-13
- HighBoston Scientific myLUX Patient Application Recalled for Data Transmission Failure
FDA (Devices) · 2024-10-30
- ModerateBoston Scientific Recalls LATITUDE Patient Management System Software
FDA (Devices) · 2013-05-29
- ModerateBoston Scientific LATITUDE Programming System Software Update Recall
FDA (Devices) · 2020-03-25