The Recall Desk
HighFDA (Devices)·Z-1216-2023·Announced 2023-03-15

LATITUDE NXT Remote Patient Monitoring System Alerts Not Displaying

Boston Scientific's LATITUDE NXT system failed to display cardiac alerts for 1,531 patient records during 2022. Contact Boston Scientific to determine if your patients were affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall affecting a remote cardiac monitoring system. No illnesses or injuries are reported in the source text. The hazard is theoretical—missing HeartLogic alerts could potentially delay clinical response—but constitutes a risk-of-harm product where injury has not yet been documented, meeting the criteria for High severity.

Plain-English summary

The LATITUDE NXT Remote Patient Management System is designed to monitor cardiac patients remotely and provide alerts based on the HeartLogic Index. During an 8-month interval in 2022, the system failed to send enablement requests to U.S. LATITUDE Customer Support, preventing HeartLogic Index readings and associated Yellow Alerts from displaying to healthcare providers for certain patients.

The issue affected 1,531 patient data records. Healthcare facilities and providers across multiple U.S. states were impacted, including facilities in California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, and Wisconsin.

Healthcare providers using the LATITUDE NXT system should contact Boston Scientific to determine whether their patients' alerts were affected by this issue and to review relevant monitoring data from the affected 8-month period in 2022.

The recalled product

Product
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Remote Patient Monitoring
Hazard
  • alert-non-display
  • monitoring-system-failure
  • data-visibility-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 00802526613876

Distribution

Distributed nationwide across the United States.

Related recalls

Same category