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LATITUDE NXT Remote Patient Management System, LATITUDE NXT… recallZ-1216-2023 · Boston Scientific Corporation · initiated Feb 2, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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..

FDA root cause category: Software Manufacturing/Software Deployment

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-1216-2023
Status
Open, Classified
Initiated by the company
Feb 2, 2023
Posted by the FDA
Mar 3, 2023
Recalling firm
Boston Scientific Corporation
Quantity
1,531 patient data records
Product code
LWS
FDA submissions
P910077
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.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00802526613876

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

33 devices cleared under P910077 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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