myCordella Handheld Patient Reader
Endotronix, Inc. · Model 100102-01 · UDI-DI 00850008997013
Description
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System. The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.
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Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery ( |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Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery ( |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 | 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 | 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 |
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