LATITUDE NXT Remote Patient Management System — Class II medical device recall Z-1216-2023
Ongoing recall by Boston Scientific Corporation, reported 2023-03-15, distributed nationwide. Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S.
| Recall number | Z-1216-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2023-02-02 |
| Classified | 2023-03-03 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 1,531 patient |
| UPC / GTIN / UDI-DI | 00802526613876 |
| Model numbers | 6460 |
Product
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Reason for recall
Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1216-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.