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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,531
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
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