St. Jude Medical has recalled 1,036 units of its CardioMEMS HF Pressure Measurement Systems due to software configuration errors. The recall includes the Patient Electronics System (PES) and the Hospital Electronics System (HES). A cloud data migration caused the systems to revert to an outdated configuration, which leads to incorrect or inaccurate pulmonary artery pressure readings for heart failure patients. This issue affects devices distributed worldwide, including 40 U.S. states.
Inaccurate pressure readings from these systems can cause healthcare providers to make incorrect treatment decisions for patients with heart failure. This could potentially result in serious medical complications, though no injuries or incidents have been reported to date.
Patient Electronics System (PES) interfaces with the MN6000 Heart Failure Web Application.
Hospital Electronics System (HES) interfaces with the MN6000 Heart Failure Web Application.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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