Recall Z-0226-2025— Boston Scientific Corporation

Name: FDA recall Z-0226-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-06

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2024-09-06. It names one FDA 510(k) clearance: K231328. 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: 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-09-06
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp·cleared 2023-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.