FDA Medical devices recall ·
Boston Scientific myLUX Patient Application for an Apple Mobile device… recall
- Recall number
- Z-0226-2025
- Date
- (initiated September 6, 2024)
- Company / brand
- Boston Scientific Corporation
4100 Hamline Ave N, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7,649 apps
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 00802526618215, Versions 2.0.101, 2.0.110
Distribution
Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.
States: Alabama Arizona California Colorado Florida Georgia Idaho Kentucky Massachusetts Maryland North Carolina New Jersey New York Ohio Puerto Rico South Carolina Utah Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0226-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.