PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: January 29, 2025 Initiated: November 6, 2024 #Z-0987-2025

Product Description

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.

Details

Recalling Firm
St. Jude Medical
Units Affected
25 systems
Distribution
U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by St. Jude Medical. Units affected: 25 systems.
Why was this product recalled? ▼
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2025. Severity: Moderate. Recall number: Z-0987-2025.

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