Recall archive / FDA device enforcement
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS"... — FDA record Z-0987-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 6, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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 II
- Recalling firm
- St. Jude Medical
- Quantity
- 25 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0987-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 29, 2025
- Recall initiation date
- Nov 6, 2024
- Center classification date
- Jan 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.