St. Jude Medical recalls CardioMEMS HF System PA Sensors (Model CM2000) that may operate outside intended frequency range at elevations over 2,000 ft, causing inaccurate readings. Affected units have specific UDI/DI codes listed in the recall.
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 CardioMEMS HF System PA Sensors (Model CM2000) that may provide inaccurate readings when used at elevations above 2,000 feet. This could lead to incorrect heart failure monitoring data for patients. The recall affects specific units with the listed UDI/DI codes.
The sensors may operate outside their intended radiofrequency range when readings are taken at elevations over 2,000 feet. This can cause inaccurate readings or signal acquisition difficulties, potentially leading to incorrect heart failure treatment decisions.
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 units with the listed UDI/DI codes.
Check if your CardioMEMS HF System PA Sensor has a model number CM2000 and the specific UDI/DI codes listed in the recall (e.g., M140100179, M140100180, etc.).
Verify if your device has the model number CM2000 and the specific UDI/DI codes listed in the recall.
The sensors may operate outside their intended radiofrequency range at elevations above 2,000 feet, causing inaccurate readings or signal acquisition difficulties.
Yes, check if your device has the model number CM2000 and the specific UDI/DI codes listed in the recall. If affected, contact St. Jude Medical for further instructions.
This is a low-risk issue that could lead to inaccurate readings, but it does not cause immediate injury or serious harm. The risk is specific to high elevations.
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-1224-2023 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1224-2023 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.
