Z-0226-2025 Class II Ongoing
FDA device recall Z-0226-2025 was initiated by Boston Scientific Corporation on Sep 6, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 7,649 apps.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Sep 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,649 apps
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.
Reason for Recall
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.
Distribution Pattern
Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.
Code Information
GTIN 00802526618215, Versions 2.0.101, 2.0.110
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0226-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026