St. Jude Medical recalls CardioMEMS HF System Hospital Electronics (HES) Model CM3000 due to potential radiofrequency emissions interfering with pacemakers, defibrillators, and other medical devices during use.
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 its CardioMEMS HF System Hospital Electronics (HES) Model CM3000 because it emits radiofrequency signals that could interfere with other medical devices like pacemakers and defibrillators when used close together. This risk exists during readings of the system's data for heart failure patients.
The CardioMEMS HES Model CM3000 emits radiofrequency signals that exceed certain emissions limits. When this device is used in close proximity to other active medical devices (like pacemakers or defibrillators) during readings, it can cause interference with those devices' normal operation.
Heart failure patients using the CardioMEMS HF System for monitoring are most at risk, as the device requires close proximity to other medical devices during readings. Patients with pacemakers, defibrillators, or continuous glucose monitors may experience interference.
Check for the CardioMEMS HF System Hospital Electronics (HES) Model CM3000 with serial numbers listed in the recall (e.g., M140100179, M140100180, etc.). The device is used for heart failure monitoring and provides pulmonary artery pressure data.
Verify if your CardioMEMS HF System Hospital Electronics (HES) Model CM3000 has a serial number listed in the recall (e.g., M140100179, M140100180, etc.).
If you have the recalled device, contact St. Jude Medical directly for further instructions on how to address the issue.
Yes, if you have the CardioMEMS HF System Hospital Electronics (HES) Model CM3000 with a serial number listed in the recall, it is affected.
Pacemakers, defibrillators, continuous glucose monitors, and other bio-wearable sensors that are active during readings may experience interference.
Check the serial number on your device against the list of serial numbers provided in the recall notice.
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-1221-2023 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1221-2023 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.
