Home › Device types › MOM
System, Hemodynamic, Implantable
FDA product code MOM · Class 3 · Unknown
39
Registered devices
11,799
Adverse events
13
Recalls
0
510(k) clearances
Devices with this code
CardioMEMS™ — ST. JUDE MEDICAL, INC.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — CARDIOMEMS, INC.Cordella Calibration Equipment — Endotronix, Inc.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — ST. JUDE MEDICAL, INC.Merlin.net — CARDIOMEMS, INC.CardioMEMS™ — ST. JUDE MEDICAL, INC.CardioMEMS™ — CARDIOMEMS, INC.Cordella Sensor Delivery Kit — Endotronix, Inc.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — ST. JUDE MEDICAL, INC.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — ST. JUDE MEDICAL, INC.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — CARDIOMEMS, INC.Cordella Data Analysis Platform — Endotronix, Inc.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — CARDIOMEMS, INC.CardioMEMS™ — ST. JUDE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-03 | St. Jude Medical | 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 |
| 2024-11-06 | St. Jude Medical | Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings. |
| 2024-10-05 | St. Jude Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurat |
| 2024-10-05 | St. Jude Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurat |
| 2023-10-04 | St. Jude Medical | Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. |
| 2023-02-07 | St. Jude Medical | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,00 |
| 2023-02-07 | St. Jude Medical | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,00 |
| 2023-02-07 | St. Jude Medical | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics |
| 2023-02-07 | St. Jude Medical | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics |
| 2023-02-07 | St. Jude Medical | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics |
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