St. Jude Medical recalls CardioMEMS HF System PA Sensor and Delivery System Model CM2000 for potential inaccurate readings at elevations over 2,000 ft. due to radiofrequency operation outside intended range. This may affect heart failure patients using the device.
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) because they can give inaccurate readings at elevations above 2,000 feet. This happens because the sensors operate outside their intended radiofrequency range at higher elevations, which could lead to incorrect heart failure monitoring data.
The sensors may operate outside their intended radiofrequency range when used 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. The recall affects specific model numbers (CM2000) sold with serial numbers listed in the recall notice.
Check if your device has the model number CM2000 and serial numbers listed in the recall notice (e.g., H24Y92, H24YB8, etc.). The device is used for heart failure monitoring.
Verify your device has model number CM2000 and a serial number from the list provided in the recall notice.
Reach out to St. Jude Medical for guidance on next steps if your device is affected.
The sensors may operate outside their intended radiofrequency range at elevations over 2,000 feet, causing inaccurate readings or signal acquisition difficulties.
No, but you should check if your device is affected and contact St. Jude Medical for guidance.
Check your device's serial number against the list provided in the recall notice and 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-1223-2023 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1223-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
