CardioMEMS Heart Monitoring System Emissions May Interfere With Pacemakers
FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.
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 FDA Class II recall carries significant risk-of-harm because radiofrequency emissions could interfere with life-critical implanted medical devices such as pacemakers and cardiac defibrillators. No illnesses or injuries have been reported, qualifying it for a High rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The CardioMEMS HF System Patient Electronics System (PES), Model CM1010, is a medical device used to monitor pulmonary artery pressure and help physicians manage heart failure patients. FDA is recalling 200 units because radiofrequency (RF) emissions from these devices exceed certain limits and have the potential to cause interference with other implanted medical devices.
The recalled device can potentially interfere with implantable medical devices including pacemakers, cardiac defibrillators, continuous glucose monitors, implantable neurostimulators, and other bio-wearable sensors, especially when the CardioMEMS system is in close proximity during readings. The affected units have been distributed worldwide, including throughout the United States and in Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, the United Kingdom, and the United Arab Emirates.
Patients and healthcare providers with affected CardioMEMS devices should check the FDA recall notice to identify their specific device serial numbers and consult with their healthcare provider for guidance. Refer to the FDA recall notice for the complete list of affected serial numbers and additional recall information.
The recalled product
- Product
- CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, 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
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 05414734509176
- Serial Numbers: M140300439
- M140300440
- M140300441
- M140300445
- M140300446
- M140300447
- M140300449
- M140300450
- M140300451
- M140300454
- M140300458
- M140300459
- M140300460
- M140300463
- M140500480
- M140500486
- M140800987
- M140800988
- M140800992
Distribution
Distributed nationwide across the United States.
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