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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE" NXT Remote Patient Management System

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  Class 2 Device Recall LATITUDE" NXT Remote Patient Management System see related information
Date Initiated by Firm February 02, 2023
Date Posted March 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-1216-2023
Recall Event ID 91646
PMA Number P910077 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Code Information UDI-DI: 00802526613876
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact United States Technical Services
800-227-3422
Manufacturer 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..
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action 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.
Quantity in Commerce 1,531 patient data records
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC
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