FDA Device Intelligence
HomeDevice 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

Recent recalls

DateFirmReason
2025-02-03St. Jude MedicalDue to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient
2024-11-06St. Jude MedicalDue to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
2024-10-05St. Jude MedicalAs a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurat
2024-10-05St. Jude MedicalAs a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurat
2023-10-04St. Jude MedicalPotential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
2023-02-07St. Jude MedicalSelect CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,00
2023-02-07St. Jude MedicalSelect CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,00
2023-02-07St. Jude MedicalRadiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics
2023-02-07St. Jude MedicalRadiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics
2023-02-07St. Jude MedicalRadiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.