Cardiomems Hospital Electronics System

The Cardiomems HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number (less than 1%) of implanted Cardiomems PA sensors (model CM2000) have operated outside of this intended radiofrequency range at least once over the life of the implant when interrogated by Cardiomems patient or hospital systems (models CM1100 and CM3000). Operating frequency may be affected by atmospheric conditions, elevation, pulmonary artery (pa) pressure, and unique sensor and patient characteristics.

Recall start date: February 7, 2023