Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" H
Summary
The FDA issued a Class II for Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN600 by St. Jude Medical. 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..
Details
Source
Device Recall
External ID
Z-0987-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 25 systems
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.
Distribution
U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-06
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
St. Jude Medical has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (St. Jude Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does St. Jude Medical have FDA actions?
St. Jude Medical has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0987-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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