Recall Z-1216-2023— Boston Scientific Corporation

Name: FDA recall Z-1216-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-02

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2023-02-02. FDA's recall record names no specific 510(k) clearance for this event. Product: LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.. Reason: 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...

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-02-02
Firm location: Saint Paul, MN, United States

Product description

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..

Data sourced from openFDA. This site is unofficial and independent of the FDA.