# FDA recall Z-0987-2025

> **St. Jude Medical** · Class II · device recall initiated 2024-11-06.

## Product

Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000)  (Which interfaces with CardioMEMS" Hospital System model CM3100)    The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.

## Reason for recall

Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

## Distribution

U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA.  O.U.S.: N/A

## Key facts

- **Recall number:** Z-0987-2025
- **Recalling firm:** St. Jude Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-06
- **Report date:** 2025-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0987-2025

## Citation

> AI Analytics. FDA recall Z-0987-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0987-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*