# FDA recall Z-0226-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2024-09-06.

## Product

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

Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.

## Key facts

- **Recall number:** Z-0226-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-06
- **Report date:** 2024-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0226-2025

## Citation

> AI Analytics. FDA recall Z-0226-2025. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0226-2025. Source: US FDA. Licensed CC0.

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