Reported Jan 29, 2025 · Ongoing
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS"…
St. Jude Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical · 387 Technology Cir Nw Ste 500 · Atlanta, GA · 30313-2424
Is this the product you have?
- 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.
- Lot codes and dates
- Merlin.net Patient Care Network Heart
- Failure Web Application Model NumberMN6000
- UDI-DI code05414734510035
- CardioMEMS Hospital system ModelCM3100
- Serial Numbers
M220200018M220200028M220300070M220300173M220300186M220700135M220900036M220900045M220900050M220900052M220900089M220900109M221100017M221100020M221100043M221100060M230500037M230500038M230900026M230900037M231100022M240100031M240100086M240500086M240500088
- Amount recalled
- 25 systems
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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