CardioMEMS PA Sensor Operates Outside Frequency Range at High Elevations
Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential for inaccurate readings in a critical medical monitoring device affecting heart failure management decisions. Per the rubric, theoretical risks of harm without reported illness are rated at most 3 (High).
Plain-English summary
St. Jude Medical is recalling select CardioMEMS HF System PA Sensors (Model CM2000) that operate outside of their intended frequency range when readings are taken at elevations above approximately 2,000 feet (610 meters) above sea level.
The CardioMEMS system measures pulmonary artery pressure to help physicians monitor and manage heart failure patients. When the device operates outside its intended radiofrequency range at high elevations, it may provide inaccurate readings or encounter difficulties acquiring sensor signals. This could affect the reliability of hemodynamic data used for treatment decisions.
Approximately 36,875 units with specific serial numbers have been identified in this recall. The affected units are distributed across the United States and 22 other countries including Canada, France, Germany, Spain, the United Kingdom, Australia, and others. Healthcare providers and patients with these device serial numbers should contact St. Jude Medical for information regarding their specific device.
The recalled product
- Product
- 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
- Manufacturer
- St. Jude Medical
- Hazard
- inaccurate-readings
- signal-acquisition-failure
- high-altitude-malfunction
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 05414734509237
- Serial numbers: H24Y92
- H24YB8
- H24YJY
- H24YSK
- H24YY9
- H24YZG
- H24Z3B
- H24Z8S
- H24ZEE
- H24ZF7
- H24ZHH
- H24ZMN
- H24ZTV
- H24ZVP
- H24ZWL
- K24YFW
- K25YCE
- K25YEY
- K25YKN
Distribution
Distributed nationwide across the United States.
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