Recall Z-0987-2025 ยท MOM System, Hemodynamic, Implantable
St. Jude Medical
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
| Date | Jan 17, 2025 (initiated Nov 6, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 11/06/2024, the firm sent an "URGENT: MEDICAL DEVICES CORRECTION", to customers to inform them that on September 30, 2024, the Merlin.net PCN HF Portal (MN6000) was migrated to the cloud database and following the migration, some customers reported that their Hospital Systems were unable to transmit to the Merlin.net PCN. User Action Requested: Abbott requests that clinicians take the following actions: The Impacted CM3100 Hospital System devices at your facility is/are listed in the enclosed Appendix. o For a Hospital System marked SESSIONS SENT no further correction is needed. o Hospital |
| Quantity | 25 systems |
| Distribution | U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.