CardioMEMS HF System

Medical Device Correction: CardioMEMS™ Hospital System, Backend Web Application and Merlin.net Patient Care Network (PCN) HF Portal – February 2025

Abbott is notifying clinicians of two issues based on customer complaints that affect Merlin.net™ PCN patient profiles. These issues are very specific and only impact a small subset of patient data.

Issue 1: Merlin.net PCN may create duplicate patient profiles after a follow-up session with certain CM3100 units.

Issue 2: Certain Hospital System follow-up session readings may appear in another patient’s profile.

For potentially impacted CM3100 Hospital Systems, Abbott is requesting that these systems be proactively powered on to complete a database synchronization and clear the CM3100 for future use. For impacted units Abbott is requesting that clinicians follow specific instructions from the clinician notifications.

Medical Device Correction: Follow-Up Notification - CardioMEMS Patient Electronics System and Merlin.net Patient Care Network – November 2024

Follow-up from the previous customer notification in October 2024. During the migration, 3.9% of CardioMEMS™ Patient Electronics Systems (PES) CM1100 were reverted to an outdated configuration file in the cloud database that may have resulted in incorrect pulmonary artery (PA) pressure readings. Configuration files are utilized by the PES to interface with the implanted CardioMEMS™ PA Sensor and translate raw sensor data to PA pressures. Abbott is recommending replacement of the affected PES that are resisting correction of their configuration file.

Medical Device Correction: CardioMEMS Patient Electronics System and Merlin.net Patient Care Network – October 2024

Abbott migrated the Merlin.net PCN HF Portal (MN6000) data to the cloud on September 30, 2024. After the software migration approximately 3.9% of CM1100 Patient Electronics Systems (PES) were reverted to an outdated configuration file in the cloud database that may have resulted in incorrect pulmonary artery (PA) pressure readings. Also, customers reported that their Hospital Systems were unable to transmit to the Merlin.net PCN. Abbott has implemented a database correction and software update on October 15 to begin resolving these issues. Affected CM3000 Hospital Electronics Systems were manually updated to correct the issue.

Medical Device Field Safety Notices: CardioMEMS Patient Electronics System — October 2023

Abbott is notifying patients and clinicians of an issue with the CardioMEMS™ Patient Electronics System (PES) and providing additional instructions to supplement the Instructions for Use. PES units manufactured from December 2017 onward that include the power connector plug housed in the connector cover in the back of the device may become frayed or damaged over time. Damage and fraying of the power connector plug can occur with repeated bending or manipulation beyond 90 degrees. This communication is to bring awareness, share the actions Abbott is taking, emphasize existing Instructions for Use and to provide important additional instructions to supplement the Instructions For Use.

It is safe for patients to continue using their device when the power connector plug is undamaged and properly connected to the power adapter cable secured to the back of the PES.

Medical Device Correction: CardioMEMS HF System — February 2023

Abbott is notifying clinicians of two issues with the CardioMEMS™ HF System and providing important additional instructions to supplement the Instructions for Use. Select CardioMEMS PA Sensors may operate outside of the intended radiofrequency range at higher elevations, and the radiated radiofrequency emissions of CardioMEMS Hospital (Model CM3000) and Patient Electronics Systems exceed certain emissions limits set by the voluntary CISPR standard. This communication is to bring awareness, share the actions that Abbott is taking, emphasize existing Instructions for Use and to provide important additional instructions to supplement the Instructions for Use.

No increase in patient harm or adverse events have been reported as a result of these issues, and it is safe to continue using these devices.