—#198402

Product

LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P910077
Affected lot / code info: UDI-DI: 00802526613876

Why it was 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..

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

The recalling firm issued letters to LATITUDE Healthcare Professionals via third-party Federal Express with signature at the account required on 2/2/2023. The letter informed the HCP that records indicate they may have U.S. patients who do not have HeartLogic enabled as the HCP may have intended in the Model 6460 U.S. LATITUDE NXT Patient Management System. The patients included within the enclosed list are scheduled to have HeartLogic enabled in LATITUDE ON 2/14/2023. The letter provides the clinical impact and recommendations. The recommendations include: (1) Distribute this information to appropriate HCPs within your center who manage HeartLogic alerts for the patients in the enclosed list; and (2) If you do NOT want HeartLogic enabled in LATITUDE for patients in the enclosed list, contact Boston Scientific LATITUDE Customer Support via latitude@bsci.com before 2/14/2023 and identify which patients should NOT be enabled. On 2/14/2023, BSC will correct the data on the Model 6460 LATITUDE Server for affected patients, unless a request not to enable is received by the firm prior to this date. Update: on 02/14/2023, Boston Scientific sent an additional letter, due to the original letter being lost in the mail. The revised letter advised customers to email LATITUDE Custoemr Support to have HeartLogic disabled.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: US Nationwide distribution to the healthcare facilities and healthcare providers are located in CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, ME, MD, MA, NV, NH, NJ, NY, NC, OH, PA, RI, SC, TN TX, VA, WA, WV, and WI.

Timeline

Recall initiated: 2023-02-02
Posted by FDA: 2023-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198402. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.