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 Alerts, 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 risk-of-harm product (delayed clinical intervention for arrhythmia) where no specific injuries or illnesses have been reported yet, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Boston Scientific Corporation is recalling the LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System, specifically the SERVER SW LAT CLARITY DS EU software (Model Number 7246, All Versions, Current 7.7). The recall is due to a potential delay in Atrial Fibrillation (AF) Burden Alert notifications.
The affected software supports the Insertable Cardiac Monitors (ICMs). A delay in these notifications may result in a delayed clinical evaluation or therapeutic intervention for patients with atrial arrhythmias. The product was distributed worldwide and nationwide in the United States.
No specific instructions for consumers are provided in the source text, but the recall indicates a risk to the timeliness of clinical care for patients relying on these alerts.
The recalled product
- Product
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
- Manufacturer
- Boston Scientific Corporation
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: 00802526613883
Distribution
Distributed nationwide across the United States.
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