CardioMEMS Hospital Electronics System RF Emissions May Interfere With Implanted Devices
St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.
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 recall involves a Class II medical device with potential to interfere with life-sustaining implanted devices such as pacemakers and defibrillators during normal operation. While no injuries or deaths have been reported, the theoretical risk posed to critical medical devices meets the High severity threshold per the rubric's criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
St. Jude Medical is recalling the CardioMEMS HF System Hospital Electronics System (HES), Model CM3000, a device that provides pulmonary artery pressure measurements to help manage heart failure patients. The recall affects 1,905 units distributed worldwide, including the United States and 22 other countries.
The CardioMEMS HES emits radiofrequency (RF) energy that exceeds certain regulatory emission limits. When the system is active during patient readings, these RF emissions have the potential to interfere with other medical devices positioned in close proximity, including implantable pacemakers, cardiac defibrillators, neurostimulators, continuous glucose monitors, and bio-wearable sensors.
Hospitals and physicians using the CardioMEMS HF System should review the recall notice and follow St. Jude Medical's guidance regarding the affected units. Patients with implanted medical devices such as pacemakers or defibrillators should speak with their healthcare provider about their use of the CardioMEMS system and the implications of this recall.
The recalled product
- Product
- CardioMEMS HF System Hospital Electronics System (HES), 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 physician
- Manufacturer
- St. Jude Medical
- Hazard
- radiofrequency-interference
- implanted-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 05415067029331
- Serial Numbers: M140100179
- M140100180
- M140100181
- M140100182
- M140100183
- M140100184
- M140100185
- M140100186
- M140200187
- M140200188
- M140200190
- M140200191
- M140200193
- M140200196
- M140200204
- M140200205
- M140200213
- M140200215
- M140200216
Distribution
Distributed nationwide across the United States.
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