St. Jude Medical recalls CardioMEMS HF System Patient Electronics (PES) Model CM1010 due to potential radiofrequency emissions interfering with implantable medical devices like pacemakers and defibrillators.
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
St. Jude Medical is recalling the CardioMEMS HF System Patient Electronics (PES) Model CM1010 because its radiofrequency emissions could interfere with other medical devices such as pacemakers and defibrillators. This risk occurs when the device is used near active medical equipment during readings.
The device emits radiofrequency (RF) signals that exceed certain emissions limits. When used in close proximity to other medical devices like pacemakers, defibrillators, or continuous glucose monitors, these signals could cause interference with their normal operation during readings.
Heart failure patients using the CardioMEMS HF System Patient Electronics (PES) Model CM1010 are most at risk, as the device may interfere with implantable medical devices like pacemakers and defibrillators during readings.
Check if your device has the model number CM1010 and serial numbers listed in the recall notice (e.g., M140300439, M140300440, etc.). The CardioMEMS HF System provides pulmonary artery pressure data for heart failure monitoring.
Verify your device model number is CM1010 and serial numbers match those listed in the recall notice.
If you have other medical devices, check for interference during readings by noting any unusual symptoms or device malfunctions.
The recall states the emissions may interfere with other medical devices, but does not mention causing serious injury or death.
Check if your device has model number CM1010 and serial numbers listed in the recall notice (e.g., M140300439, M140300440, etc.).
The recall does not specify a remedy, so contact St. Jude Medical for guidance on monitoring for interference.
We’ve drafted a message you can send St. Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1219-2023 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1219-2023 from St. Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
