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Recall Observatory FDA recall evidence

Device product

Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

Z-0226-2025

September 06, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 95441
Status
Ongoing
Classification
Class II
Quantity
7,649 apps
Official record key
device-enforcement:Z-0226-2025

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.