PMA · Approved
Recalled · Class II · 2025Cardiomems HF Pressure Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · MOM System, Hemodynamic, Implantable
Approved on May 28, 2014 through premarket approval, which rests on the device’s own clinical evidence after a 1,260-day review. It has been recalled 13 times.
- Decided
- May 28, 2014
- Review
- 1,260 days
- Class
- Class III
- Product code
- MOM
- Recalls
- 13
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100045 has 90 supplements since 2014: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 8 |
| 2017 | 8 |
| 2018 | 9 |
| 2019 | 8 |
| 2020 | 6 |
| 2021 | 11 |
| 2022 | 6 |
| 2023 | 7 |
| 2024 | 8 |
| 2025 | 7 |
| 2026 | 8 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2025 | Class II | Z-1427-2025 | Software design | 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… |
| Nov 6, 2024 | Class II | Z-0987-2025 | Under Investigation by firm | 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 | Under Investigation by firm | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings. |
| Oct 5, 2024 | Class II | Z-0989-2025 | Under Investigation by firm | 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 readings. |
| Oct 4, 2023 | Class II | Z-0218-2024 | Device Design | Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. |
| Feb 7, 2023 | Class II | Z-1225-2023 | Device Design | 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; operation outside of the intended… |
| Feb 7, 2023 | Class II | Z-1223-2023 | Device Design | 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; operation outside of the intended… |
| Feb 7, 2023 | Class II | Z-1224-2023 | Device Design | 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; operation outside of the intended… |
| Feb 7, 2023 | Class II | Z-1218-2023 | Device Design | 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 certain emissions limits and have the… |
| Feb 7, 2023 | Class II | Z-1221-2023 | Device Design | 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 certain emissions limits and have the… |
| Feb 7, 2023 | Class II | Z-1219-2023 | Device Design | 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 certain emissions limits and have the… |
| Feb 7, 2023 | Class II | Z-1220-2023 | Device Design | 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 certain emissions limits and have the… |
| Jun 14, 2018 | Class II | Z-2522-2018 | Process control | 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 5. While this error message is… |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MOM devicesMOM System, Hemodynamic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MOM
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOM
Too few MOM 510(k)s in any year since 2007 to give a median.
Recalls per year · MOM
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOM
2,189in 2025
MAUDE reports naming product code MOM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 34 |
| 2016 | 8 | — | 0 | 61 |
| 2017 | 8 | — | 0 | 291 |
| 2018 | 9 | — | 0 | 1,212 |
| 2019 | 8 | — | 0 | 672 |
| 2020 | 6 | — | 0 | 695 |
| 2021 | 11 | — | 0 | 713 |
| 2022 | 6 | — | 0 | 724 |
| 2023 | 7 | — | 1 | 1,886 |
| 2024 | 16 | — | 3 | 1,916 |
| 2025 | 24 | — | 0 | 2,189 |
| 2026 | 18 | — | 0 | — |
https://510kreport.com/device/P100045 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100045: Cardiomems HF Pressure Measurement System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100045
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026