St. Jude Medical recalls CardioMEMS HF System Patient Electronics (PES) Model CM1100 due to potential interference with medical devices like pacemakers and glucose monitors during readings.
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 CM1100 because it may emit radiofrequency signals that interfere with other medical devices such as pacemakers, cardiac defibrillators, or glucose monitors when used near them. This could cause malfunctions in these devices during readings.
The CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010, CM1100, and Hospital Electronics Systems (HES) Model CM3000 emit radiofrequency signals that exceed certain emissions limits. When these devices are in close proximity to other medical devices (like pacemakers, defibrillators, or glucose monitors) during readings, they can cause interference that may lead to malfunctions in those devices.
Patients with heart failure who use the CardioMEMS HF System Patient Electronics (PES) Model CM1100 are most at risk. The system may interfere with other medical devices like pacemakers, cardiac defibrillators, or continuous glucose monitors when they are in close proximity during readings.
Check if your CardioMEMS HF System Patient Electronics (PES) has the model number CM1100. The system was sold with specific serial numbers listed in the recall notice, including P150800220 through P161201796 and other numbers.
Identify if your CardioMEMS HF System Patient Electronics (PES) has model number CM1100.
The device may emit radiofrequency signals that interfere with other medical devices like pacemakers, cardiac defibrillators, or continuous glucose monitors when in close proximity during readings.
Check if your CardioMEMS HF System Patient Electronics (PES) has model number CM1100. The affected units have specific serial numbers listed in the recall notice.
Check if your device is affected by reviewing the list of serial numbers provided in the recall notice. If it is affected, contact St. Jude Medical for further instructions.
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-1220-2023 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1220-2023 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.
