# P100045: Cardiomems HF Pressure Measurement System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: May 28, 2014 after 1,260 days
- Product code: MOM (System, Hemodynamic, Implantable)
- Device class: 3
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 3, 2025 · Class II · Z-1427-2025: 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 wh
- Nov 6, 2024 · Class II · Z-0987-2025: Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
- Oct 5, 2024 · Class II · Z-0988-2025: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure reading
- Oct 5, 2024 · Class II · Z-0989-2025: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure reading
- Oct 4, 2023 · Class II · Z-0218-2024: Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
- Feb 7, 2023 · Class II · Z-1225-2023: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; oper
- Feb 7, 2023 · Class II · Z-1223-2023: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; oper
- Feb 7, 2023 · Class II · Z-1224-2023: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; oper
- Feb 7, 2023 · Class II · Z-1218-2023: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certai
- Feb 7, 2023 · Class II · Z-1221-2023: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certai
- Feb 7, 2023 · Class II · Z-1219-2023: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certai
- Feb 7, 2023 · Class II · Z-1220-2023: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certai
- Jun 14, 2018 · Class II · Z-2522-2018: Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 

Source page: https://510kreport.com/device/P100045
Methodology: https://510kreport.com/methodology