Recall Z-0987-2025— St. Jude Medical
Class II · Ongoing
Class II FDA medical device recall by St. Jude Medical, initiated 2024-11-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings..
- Recalling firm
- St. Jude Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-06
- Firm location
- Atlanta, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.