Recall Z-1427-2025 ยท MOM System, Hemodynamic, Implantable
St. Jude Medical
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 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 p
| Date | Mar 21, 2025 (initiated Feb 3, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | Recall involves 3 populations of users associated with patient profile duplication situations. Customer Notifications were hand-delivered to healthcare providers between 2/3 and 2/14/2025: Population 1 was notified that an issue was identified where Merlin.net creates duplicate patient profiles after a follow-up session with a CM3100. Population 1 instructed to: "Review Appendix A to identify CM3100 Hospital Systems and affected patients (Patient A and Patient B). "Make appointment with Abbott representative for on-site visit. "Pause use of CM3100 or CM3000 Hospital System to perform follow-u |
| Quantity | 193 devices |
| Distribution | U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.