# FDA recall Z-0989-2025

> **St. Jude Medical** · Class II · device recall initiated 2024-10-05.

## Product

CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM  CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000  Merlin.net Patient Care Network (PCN) Heart Failure Web Application  (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)).  Model Number MN6000

## Reason for recall

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and the countries of  Australia, and Canada.

## Key facts

- **Recall number:** Z-0989-2025
- **Recalling firm:** St. Jude Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-05
- **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-0989-2025

## Citation

> AI Analytics. FDA recall Z-0989-2025. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0989-2025. Source: US FDA. Licensed CC0.

---

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