FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0226-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2024-09-06
- Posted
- 2024-10-25
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- GTIN 00802526618215, Versions 2.0.101, 2.0.110
- 510(k) numbers
- ["K231328"]
- PMA numbers
- not on file
- Product code
- MXD
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28