Boston Scientific myLUX Patient Application for an Apple… recallZ-0226-2025 · Boston Scientific Corporation · initiated Sep 6, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
FDA root cause category: Under Investigation by firm
What the company is doing
A field action/communication with Health Care Providers (HCPs) for affected patients was initiated on September 6, 2024, to inform them of the issue and provide the necessary patient data and connection support. Clinicians and patients were contacted via telephone calls. The BSC RhythmCARE team first called clinicians to describe the monitoring problem. With permission of the clinician, RhythmCARE Support contacted the patient to request a patient-initiated interrogation of the insertable cardiac monitor. Next, they offered options to troubleshoot and resolve the monitoring problem. In most cases, the troubleshooting included providing a BSC provided mobile monitor, in a singular case, the patients chose to buy a new mobile phone. The goal of these troubleshooting calls was to re-establish patient monitoring as scheduled. Recommendations were provided on an individual basis
Recall details
- Recall number
- Z-0226-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 6, 2024
- Posted by the FDA
- Oct 25, 2024
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 7,649 apps
- Product code
- MXD
- FDA submissions
- K231328
- Distribution
- Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.
Product description
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Code information (models, lots, serial numbers)
GTIN 00802526618215, Versions 2.0.101, 2.0.110
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- myLUX™ Patient App 2939Boston Scientific Corporation · Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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