St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics…

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

On 11/14-18/24, the firm sent an updated Notification informing customer that Abbott is recommending replacement of the affected Patient Electronics System (PES) that are resisting correction of their configuration file. On 12/13-16/2024, the firm sent an updated Notification for the Hospital Electronic Systems (HES) regarding inaccurate Pulmonary Artery (PA) reading. On October 15, 2024, Abbott initiated a database correction to return affected PES to their intended configuration files. After continued monitoring, Abbott has identified a subset of units that is resisting correction and is retaining their incorrect configuration file. To ensure impacted PES units return to transmission of accurate data, Abbott recommends that clinicians take the following actions: 1 Review the attached appendix which includes a complete listing of impacted patients PES systems. -Patients with a date listed have already successfully connected and resumed sending accurate data. This date corresponds to the return of accurate PA pressures being sent by the PES. From this date forward, the data may be used for patient management. -Patients without a date listed have not yet resumed sending accurate data. Please encourage patients to send daily data transmissions (PES readings) to ensure the correction can be initiated. 2 PA pressures taken between 9/30/2024 and the listed date on the attachment may still not be accurate even after the database correction and it is recommended not to use for patient management. For HES units, review the appendix to see patient sensors that have been impacted by the affected HES between September 30, 2024 and the HES correction date, and take action as recommended below: 1 If the HES was used to take a follow-up pressure reading it is recommended to ignore that reading for clinical decision making or patient management. 2 If the affected HES was used for implant or recalibration, please contact Abbott Rep or Remote Care Technical Support at 1-844

• FDA enforcement recordOfficial FDA database entry for Z-0989-2025
• FDA device classification · MOMOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
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Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.