System, Hemodynamic, Implantable
FDA product code MOM · Class III (high risk) · Cardiovascular
0510(k) clearances
2PMA approvals
13recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1427-2025 Class II | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model…Due to issues associated with data migration of patient information and results to a Cloud service, the firm… | St. Jude Medical | 02/03/2025Open, Classified |
| Z-0987-2025 Class II | Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000)…Due to a data migration from on-premises server to the cloud environment, some customers reported that they… | St. Jude Medical | 11/06/2024Open, Classified |
| Z-0989-2025 Class II | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics…As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to… | St. Jude Medical | 10/05/2024Open, Classified |
| Z-0988-2025 Class II | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics…As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to… | St. Jude Medical | 10/05/2024Open, Classified |
| Z-0218-2024 Class II | CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly…Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. | St. Jude Medical | 10/04/2023Open, Classified |
| Z-1225-2023 Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS…Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher… | St. Jude Medical | 02/07/2023Open, Classified |
| Z-1224-2023 Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS…Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher… | St. Jude Medical | 02/07/2023Open, Classified |
| Z-1223-2023 Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS…Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher… | St. Jude Medical | 02/07/2023Open, Classified |
| Z-1221-2023 Class II | CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The…Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000… | St. Jude Medical | 02/07/2023Open, Classified |
| Z-1220-2023 Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The…Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000… | St. Jude Medical | 02/07/2023Open, Classified |
| Z-1219-2023 Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The…Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000… | St. Jude Medical | 02/07/2023Open, Classified |
| Z-1218-2023 Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The…Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000… | St. Jude Medical | 02/07/2023Open, Classified |
| Z-2522-2018 Class II | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics…Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model… | Abbott Laboratories, Inc. | 06/14/2018Terminated |