Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-0226-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 6, 2024

Date Posted: October 30, 2024

Recall Number: Z-0226-2025

Event ID: 95441

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.

Status: Ongoing

Product Quantity: 7,649 apps

Code Information:

GTIN 00802526618215, Versions 2.0.101, 2.0.110

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.

Voluntary or Mandated:

Voluntary: Firm initiated