St. Jude Medical recalls CardioMEMS Heart Failure System models CM3100 and CM4000 due to patient data duplication or missing information during cloud migration. Affected units have specific serial numbers.
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
St. Jude Medical is recalling certain CardioMEMS Heart Failure monitoring systems because some patient information may be duplicated or missing during data transfers to a cloud service. This could lead to incorrect treatment decisions for heart failure patients.
The system stores patient data that may become duplicated or missing when transferred to a cloud service. This could cause incorrect treatment decisions if healthcare providers rely on incomplete or duplicate information.
Heart failure patients using the CardioMEMS Heart Failure monitoring system with specific serial numbers. Patients using the system at clinics or hospitals where the recalled devices are installed are most at risk.
Check if your device has a serial number starting with 'M220' or 'M221' followed by numbers. The system includes the CardioMEMS Hospital System Model CM3100 and Backend Web Application Model CM4000. Devices without serial numbers are located at specific clinics.
Look for a serial number starting with 'M220' or 'M221' followed by numbers on the device. Devices without serial numbers are located at specific clinics.
The recall is due to patient data duplication or missing information during data transfers to a cloud service, which could lead to incorrect treatment decisions.
Check your device's serial number against the list provided in the recall notice. If it matches, contact St. Jude Medical for further instructions.
Yes, seven devices without serial numbers are located at Treating or Consulting Clinics.
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-1427-2025 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1427-2025 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.
