Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interf...
FDA Recall #Z-0987-2025 — Class II — November 6, 2024
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.
Recalling Firm
St. Jude Medical — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
25 systems
Distribution
U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A
Code Information
Merlin.net Patient Care Network Heart Failure Web Application Model Number: MN6000 UDI-DI code: 05414734510035 CardioMEMS Hospital system Model: CM3100 Serial Numbers: M220200018 M220200028 M220300070 M220300173 M220300186 M220700135 M220900036 M220900045 M220900050 M220900052 M220900089 M220900109 M221100017 M221100020 M221100043 M221100060 M230500037 M230500038 M230900026 M230900037 M231100022 M240100031 M240100086 M240500086 M240500088
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated