Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, car

FDA device recall Z-0226-2025 · posted 2024-10-25 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MXD

Quantity affected

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.

Date initiated

2024-09-06

Date posted

2024-10-25

Location

Saint Paul, MN

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