# FDA recall Z-1427-2025

> **St. Jude Medical** · Class II · device recall initiated 2025-02-03.

## Product

CardioMEMS Heart Failure (HF) System that consist of:  -CardioMEMS Hospital System Model CM3100  -CardioMEMS Backend Web Application Model CM4000  -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000    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 issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.

## Distribution

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

## Key facts

- **Recall number:** Z-1427-2025
- **Recalling firm:** St. Jude Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-03
- **Report date:** 2025-04-02

- **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-1427-2025

## Citation

> AI Analytics. FDA recall Z-1427-2025. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-1427-2025. Source: US FDA. Licensed CC0.

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