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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

St. Jude Medical Merlin.net Heart Failure App Recalled for Transmission Issues

Agency Publication Date: January 17, 2025
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Summary

St. Jude Medical has recalled its Merlin.net Patient Care Network Heart Failure Web Application (Model MN6000) because of a technical issue during a data migration. This problem, which occurred when moving data to cloud servers, may prevent the application from transmitting or receiving patient readings. Approximately 25 systems are affected by this issue. Because doctors use this system to monitor pulmonary artery pressure and adjust heart failure treatments, a failure to transmit data could lead to delays in critical medical management.

Risk

The failure to transmit data prevents healthcare providers from seeing changes in a patient's heart pressure in real-time. This could delay necessary adjustments to heart failure treatments, potentially resulting in worsening patient health or hospitalizations.

What You Should Do

  1. This recall affects the Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000), which interfaces with the CardioMEMS Hospital System (Model CM3100).
  2. Healthcare providers should check their systems for affected Model MN6000 applications and associated Model CM3100 hardware. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device for patient monitoring if you encounter issues transmitting or receiving data.
  4. Contact St. Jude Medical or your authorized distributor to arrange for a system correction or to confirm that your data migration has been successfully resolved.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000)
Model / REF:
MN6000
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
Lot Numbers:
05414734510035
UDI:
05414734510035

The web application interfaces with the CardioMEMS Hospital System model CM3100.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95706
Status: Active
Manufacturer: St. Jude Medical
Sold By: Hospitals; Specialized healthcare providers
Manufactured In: United States
Units Affected: 25 systems
Distributed To: California, Connecticut, Georgia, Illinois, Michigan, Minnesota, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Texas, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.