St. Jude Medical recalls CardioMEMS HF System PA Sensors (Model CM2000) that may give inaccurate readings above 2,000 ft elevation due to radiofrequency issues. This could affect heart failure monitoring accuracy.
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
St. Jude Medical is recalling certain CardioMEMS HF System PA Sensors (Model CM2000) that may provide inaccurate readings when used at elevations above 2,000 feet. This could lead to improper heart failure treatment decisions if the device is not functioning correctly.
The sensors operate outside their intended radiofrequency range at higher elevations, which can cause inaccurate readings or signal acquisition difficulties. This may lead to incorrect heart failure treatment decisions if the device is not functioning properly.
Patients using the CardioMEMS HF System for heart failure monitoring are most at risk if they live or travel at elevations above 2,000 feet. The recall applies to specific model numbers listed in the UDI/DI codes.
Check if your device has the model number CM2000 and the UDI/DI codes listed in the recall notice (e.g., M220200004, M220200005, etc.). The system is used for heart failure monitoring.
Verify your device model number matches the recalled CM2000 sensors listed in the UDI/DI codes.
The sensors may operate outside their intended radiofrequency range at elevations above 2,000 feet, causing inaccurate readings or signal acquisition difficulties.
No action is needed if you live at sea level, as the issue only affects elevations above 2,000 feet.
Check if your device has the model number CM2000 and the UDI/DI codes listed in the recall notice (e.g., M220200004, M220200005, etc.).
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-1225-2023 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1225-2023 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.
