CardioMEMS Heart Failure Monitor Recalled for Radiofrequency Emissions
St. Jude Medical is recalling certain CardioMEMS heart failure monitoring devices due to excessive radiofrequency emissions that could interfere with pacemakers, defibrillators, and other implanted medical devices when in close proximity.
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 for a medical device with potential to cause electromagnetic interference with implanted life-critical devices such as pacemakers and cardiac defibrillators. No illnesses or injuries have been reported; the hazard is potential rather than confirmed, keeping this rating below Severe.
Plain-English summary
St. Jude Medical is recalling the CardioMEMS HF System Patient Electronics System (Model CM1000). The affected units include 3,177 devices with specific serial numbers beginning with M13, M14, and M15. These devices are implanted to monitor heart failure patients by measuring pulmonary artery pressure and guiding treatment decisions.
The CardioMEMS system emits radiofrequency energy that exceeds certain FDA emissions limits. When the device is actively taking pressure readings, these emissions have the potential to interfere with other medical devices in close proximity, including implantable pacemakers, implantable cardiac defibrillators, implantable neurostimulators, continuous glucose monitors, and bio-wearable sensors.
Patients with one of the affected CardioMEMS systems and other implanted medical devices should be aware of this potential interference risk. The affected devices have been distributed worldwide, including throughout the United States and other countries.
Patients should contact their physician or St. Jude Medical for guidance regarding their specific device and any precautions to take during readings or routine monitoring.
The recalled product
- Product
- CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, 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
- Manufacturer
- St. Jude Medical
- Hazard
- radiofrequency-interference
- device-interference
- pacemaker-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 05414734509169
- Serial Numbers: M131100003
- M131100004
- M131100008
- M131100012
- M131100013
- M131100015
- M131200018
- M131200022
- M131200027
- M131200030
- M131200033
- M131200034
- M131200035
- M131200036
- M131200038
- M131200040
- M131200043
- M131200044
- M131200047
Distribution
Distributed nationwide across the United States.
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