Recall Z-0226-2025 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Boston Scientific Corporation
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
| Date | Oct 25, 2024 (initiated Sep 6, 2024) |
| Status | Open, Classified |
| 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. |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) Boston Scientific Corp, Aug 19, 2023 |