# FDA recall Z-1216-2023

> **Boston Scientific Corporation** · Class II · device recall initiated 2023-02-02.

## Product

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

## 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..

## 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.

## Key facts

- **Recall number:** Z-1216-2023
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-02
- **Report date:** 2023-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2023

## Citation

> AI Analytics. FDA recall Z-1216-2023. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1216-2023. Source: US FDA. Licensed CC0.

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