Boston Scientific Corporation: myLUX Patient Application Recalled for Cardiac Data Transmission Failure

Agency Publication Date: October 25, 2024

Summary

Boston Scientific is recalling 7,649 myLUX Patient Applications (Model 2939) used on Apple mobile devices like iPhones. This mobile application is designed to transmit heart data from an Insertable Cardiac Monitor to the LATITUDE Clarity website for healthcare provider review. The recall was initiated because the app may fail to transmit this vital data, potentially preventing doctors from seeing important changes in a patient's cardiac health. If you use this app, you should contact your healthcare provider or Boston Scientific to ensure your monitoring system is functioning correctly.

Risk

A failure to transmit data from the cardiac monitor means that potentially life-threatening heart rhythm events may not be reported to a patient's physician in a timely manner, delaying necessary medical intervention.

What You Should Do

Identify if you are using the affected software by checking the myLUX Patient Application on your Apple mobile device (iPhone). The affected versions are 2.0.101 and 2.0.110 for Model Number 2939.
Verify the GTIN number 00802526618215 associated with your application if available in your app store history or device settings.
Contact your healthcare provider or cardiologist immediately to confirm if they have been receiving your cardiac monitor transmissions and to discuss alternative monitoring if necessary.
Contact Boston Scientific Corporation directly at their Saint Paul, Minnesota facility for further instructions regarding software updates or corrective actions.
Call the FDA's medical device hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: myLUX Patient Application for Apple Mobile Devices (Model 2939)

Model / REF:

2939

UPC Codes:

00802526618215

Lot Numbers:

Version 2.0.101

Version 2.0.110

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95441

Status: Active

Manufacturer: Boston Scientific Corporation

Sold By: Apple App Store

Manufactured In: United States

Units Affected: 7,649 apps

Distributed To: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Kentucky, Massachusetts, Maryland, North Carolina, New Jersey, New York, Ohio, Puerto Rico, South Carolina, Utah, Virginia, Washington

Agency Last Updated: April 14, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you are using the affected software by checking the myLUX Patient Application on your Apple mobile device (iPhone). The affected versions are 2.0.101 and 2.0.110 for Model Number 2939.

Verify the GTIN number 00802526618215 associated with your application if available in your app store history or device settings.

Contact your healthcare provider or cardiologist immediately to confirm if they have been receiving your cardiac monitor transmissions and to discuss alternative monitoring if necessary.

Contact Boston Scientific Corporation directly at their Saint Paul, Minnesota facility for further instructions regarding software updates or corrective actions.

Call the FDA's medical device hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.