Z-0226-2025Class II

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

Name: Z-0226-2025 Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101...
Creator: Boston Scientific Corporation
Published: 2024-09-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-09-06 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application on 2024-09-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0226-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-06
Posted: 2024-10-25
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Product code: MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
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.
FDA root cause: Under Investigation by firm
Action: A field action/communication with Health Care Providers (HCPs) for affected patients was initiated on September 6, 2024, to inform them of the issue and provide the necessary patient data and connection support. Clinicians and patients were contacted via telephone calls. The BSC RhythmCARE team first called clinicians to describe the monitoring problem. With permission of the clinician, RhythmCARE Support contacted the patient to request a patient-initiated interrogation of the insertable cardiac monitor. Next, they offered options to troubleshoot and resolve the monitoring problem. In most cases, the troubleshooting included providing a BSC provided mobile monitor, in a singular case, the patients chose to buy a new mobile phone. The goal of these troubleshooting calls was to re-establish patient monitoring as scheduled. Recommendations were provided on an individual basis
Quantity in commerce: 7,649 apps
Distribution: Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.
Product codes and lots: GTIN 00802526618215, Versions 2.0.101, 2.0.110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0226-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0226-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-24

Product code MXD

K231328Class IILUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp / cleared 2023-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)