Boston Scientific Corporation: Medical Device Recall in 2023 - (Recall #: Z-1216-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 2, 2023

Date Posted: March 15, 2023

Recall Number: Z-1216-2023

Event ID: 91646

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..

Status: Ongoing

Product Quantity: 1,531 patient data records

Code Information:

UDI-DI: 00802526613876

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.

Voluntary or Mandated:

Voluntary: Firm initiated