Cordella Sensor Delivery Kit
Endotronix, Inc. · Model 100303-05 · UDI-DI 00850008997006
Description
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System. Cordella PA Sensor The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex. Delivery System The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.
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Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery ( |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Medical | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery ( |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 | 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 |
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