CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.
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: This is an FDA Class II medical device recall involving inaccurate pressure readings from a cardiac monitoring system. Although no illnesses or injuries have been reported in the recall notice, inaccurate readings in heart failure monitoring constitute a risk-of-harm product where clinical decision-making could be adversely affected.
Plain-English summary
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System, which includes the Patient Electronics System (model CM1100), Hospital Electronics System, and Merlin.net Patient Care Network web application. This system is used to monitor pulmonary artery pressure in heart failure patients.
A cloud data migration of the Patient and Hospital Electronic Systems caused the system to revert to an outdated configuration. This resulted in incorrect and inaccurate pulmonary artery pressure readings. Such inaccurate readings could affect clinical decision-making and patient care in heart failure management.
Approximately 605 units have been distributed worldwide, including U.S. nationwide distribution and international distribution to Australia and Canada. Patients and healthcare providers using this system should consult with their healthcare provider or St. Jude Medical regarding this recall.
The recalled product
- Product
- CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF S
- Manufacturer
- St. Jude Medical
- Hazard
- inaccurate-pressure-readings
- system-malfunction
Distribution
Distributed nationwide across the United States.
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