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St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" H
Recalled January 29, 2025 · FDA recall Z-0987-2025 · St. Jude Medical
Hazard
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings. · FDA Class II
Units
25 systems
Sold at
U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A
Description
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
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.
Manufacturer(s)
St. Jude Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →