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 injury has not yet been reported, fitting the High severity criteria.
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 7260, All Versions, Current 7.8). The recall involves the SERVER SW LAT CLARITY DS US software that supports these medical devices.
The recall is issued because there is a potential for a delay in Atrial Fibrillation (AF) Burden Alert notifications. 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 software was distributed worldwide and nationwide in the United States. No specific number of affected units or reported injuries is stated in the source text. Healthcare providers and patients using these devices should consult their medical professionals regarding the potential impact on their monitoring and treatment.
The recalled product
- Product
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
- 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: 00802526613838
Distribution
Distributed nationwide across the United States.
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