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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- St. Jude Medical
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Distribution:
Distributed in: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0987-2025
Related Recalls
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.