Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CardioMEMS HF System PA Sensor and Delivery System Recalled by St. Jude Medical Due to Select CardioMEMS PA Sensors (Model CM2000) operate outside...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical directly.
Affected Products
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, 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 modify heart failure treatment.
Quantity: 36875 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About St. Jude Medical
St. Jude Medical has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report