CardioMEMS PA Sensor models affected by radio-frequency range at high elevations
St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a cardiac monitoring device where operation outside intended parameters risks inaccurate readings—a critical patient safety concern—but no illnesses or injuries have been reported. This qualifies as 'High' per the rubric: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
St. Jude Medical is recalling select CardioMEMS PA Sensors (Model CM2000). The CardioMEMS HF System provides pulmonary artery hemodynamic monitoring used in the management of heart failure patients, helping physicians make treatment decisions based on pressure measurements.
These sensors may operate outside their intended radiofrequency range when readings are taken at elevations above approximately 2,000 feet (610 meters). When operation occurs outside the intended frequency range, the sensors risk producing inaccurate readings or experiencing sensor signal acquisition difficulties.
Approximately 1,905 units have been distributed worldwide, including throughout the United States and 23 other countries. Patients and healthcare providers with affected CardioMEMS systems should contact St. Jude Medical for guidance regarding their specific devices.
The recalled product
- Product
- 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
- Manufacturer
- St. Jude Medical
- Hazard
- inaccurate-readings
- sensor-signal-loss
- radio-frequency-interference
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 05415067029331: M140100179
- M140100180
- M140100181
- M140100182
- M140100183
- M140100184
- M140100185
- M140100186
- M140200187
- M140200188
- M140200190
- M140200191
- M140200193
- M140200196
- M140200204
- M140200205
- M140200213
- M140200215
- M140200216
- M140200218
Distribution
Distributed nationwide across the United States.
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