Medical Device Recall: 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 art
St. Jude Medical · November 6, 2024
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.
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.
Distribution
U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A
States Affected
CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, WA
Quantity Affected
25 systems
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0987-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.