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CardioMEMS™
CARDIOMEMS, INC. · Model CM3000 · UDI-DI 05415067029331
MOM
Prescription
0
510(k) clearances
11,799
Adverse events (226 deaths)
13
Recalls
10
Facilities
Description
Hospital Electronics System
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 profile information |
| 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Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery ( |
| 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Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery ( |
| 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 2,000 ft. (610 meters) a |
| 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 2,000 ft. (610 meters) a |
| 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 Systems (HES) Model |
| 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 Systems (HES) Model |
| 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 Systems (HES) Model |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.