Recall Z-0226-2025
Boston Scientific Corporation · initiated September 6, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Codes / lots: GTIN 00802526618215, Versions 2.0.101, 2.0.110
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-determined cause: Under Investigation by firm
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
Details
- Recall number
- Z-0226-2025
- Initiated
- September 6, 2024
- Posted by FDA
- October 25, 2024
- Product code
- MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Quantity
- 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.
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN