St. Jude Medical recalls CardioMEMS HF System Patient Electronics (PES) Model CM1000 due to potential radiofrequency interference with medical devices like pacemakers and glucose monitors during readings. Affected units have specific serial numbers listed in the recall.
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 CardioMEMS HF System Patient Electronics (PES) Model CM1000 devices because they emit radiofrequency signals that could interfere with other medical devices such as pacemakers, cardiac defibrillators, and glucose monitors when used in close proximity. This risk occurs during readings of the device.
The device emits radiofrequency emissions that exceed certain limits and can interfere with other medical devices like pacemakers, cardiac defibrillators, and continuous glucose monitors when they are in close proximity to the CardioMEMS system during readings. This interference could cause malfunctions in these medical devices.
Patients using the CardioMEMS HF System Patient Electronics (PES) Model CM1000 for heart failure monitoring are at risk if they have other medical devices that could be affected by radiofrequency emissions. The recall includes specific serial numbers listed in the notice.
Check if your CardioMEMS HF System Patient Electronics (PES) Model CM1000 has a serial number listed in the provided list of affected units (e.g., M131100003, M131100004, etc.). The recall covers specific models and serial numbers as detailed in the official notice.
Verify if your device's serial number is listed in the provided list of affected units (e.g., M131100003, M131100004, etc.).
The device emits radiofrequency emissions that could interfere with other medical devices like pacemakers, cardiac defibrillators, and glucose monitors when in close proximity during readings.
Check if your device's serial number is listed in the provided list of affected units (e.g., M131100003, M131100004, etc.).
No, but you should check if your device is affected and contact St. Jude Medical if you have a device with a listed serial number.
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-1218-2023 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1218-2023 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.
