Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LATITUDE NXT Remote Patient Management System Recalled by Boston Scientific Corporation Due to Under specific circumstances, the U.S. product registration system...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Quantity: 1,531 patient data records
Why Was This Recalled?
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..
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report