FDAFebruary 7, 2023device

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or m...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.

What to do

FDA enforcement status: Ongoing

Brands named

st jude medical

UPCs

05415067029331

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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