Boston Scientific myLUX Patient Application Recalled for Data Transmission Failure
Boston Scientific is recalling the myLUX Patient Application for Apple mobile devices because it may fail to transmit cardiac monitor data to the LATITUDE Clarity website.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (cardiac monitor) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Boston Scientific Corporation is recalling the myLUX Patient Application for Apple mobile devices, Model Number 2939, Versions 2.0.101 and 2.0.110. The recall involves 7,649 apps distributed nationwide to specific states and Puerto Rico.
The recall was initiated because patients using the application may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website. This failure in data transmission could prevent healthcare providers from receiving necessary cardiac monitoring information.
Affected users should contact Boston Scientific or their healthcare provider for instructions on how to resolve the data transmission issue. The agency has classified this as a Class II recall, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 7,649
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)
- GTIN 00802526618215
- Versions 2.0.101
- 2.0.110
Distribution
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- 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
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · data transmission failure
See all →- SevereCARDIOSAVE RESCUE intra-aortic balloon pump software correction for hemodynamic instability
FDA (Devices) · 2024-10-02
- SevereCARDIOSAVE Rescue IABP software defect poses hemodynamic instability risk
FDA (Devices) · 2024-10-02
- SevereCardiac Support Device Software Defect Risks Hemodynamic Instability
FDA (Devices) · 2024-10-02
- SeverePhilips V60 Ventilators Recalled for Connector Pin Displacement
FDA (Devices) · 2017-05-24
- HighMedtronic Recalls MyCareLink Patient Monitor Due to Data Transmission Failure
FDA (Devices) · 2016-07-13
Similar recalls
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- 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
- HighLUX-DX II Arrhythmia Detector Monitoring Function Data Collection Issue
FDA (Devices) · 2026-05-13
- HighLATITUDE NXT Remote Patient Monitoring System Alerts Not Displaying
FDA (Devices) · 2023-03-15
- HighBoston Scientific LATITUDE Programming System Recalled for Stimulation Risk
FDA (Devices) · 2018-10-03