Cordella Calibration Equipment
Endotronix, Inc. · Model 100622-00 · UDI-DI 00850008997020
Description
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System. The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include: • Interrogates the Cordella Sensor to verify proper working condition. • Facilitates linking of component serial numbers to patient IDs. • Calibrates the Cordella Sensor to a reference pressure at the time of implantation. • Trains patient on optimal Reader placement post-procedure. • Recalibrates the Cordella Sensor to a reference pressure post-implant. • CalEQ is operated by Endotronix personnel only.
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Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery ( |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Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery ( |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 | 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 |
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