Recall Z-0988-2025 ยท MOM System, Hemodynamic, Implantable
St. Jude Medical
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000
| Date | Jan 17, 2025 (initiated Oct 5, 2024) |
| Status | Open, Classified |
| Reason | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings. |
| Root cause | Under Investigation by firm |
| Action | On 11/14-18/24, the firm sent an updated Notification informing customer that Abbott is recommending replacement of the affected Patient Electronics System (PES) that are resisting correction of their configuration file. On 12/13-16/2024, the firm sent an updated Notification for the Hospital Electronic Systems (HES) regarding inaccurate Pulmonary Artery (PA) reading. On October 15, 2024, Abbott initiated a database correction to return affected PES to their intended configuration files. After continued monitoring, Abbott has identified a subset of units that is resisting correction and is re |
| Quantity | 605 units |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and the countries of Australia, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.