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.
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