St. Jude Medical is recalling approximately 193 units of the CardioMEMS Heart Failure (HF) System due to a software issue involving the migration of patient data to a cloud service. This problem has caused some patient profile information to be duplicated while other critical data is missing. The affected system components include the CM3100 Hospital System, the CM4000 Backend Web Application, and the MN6000 Merlin.net Patient Care Network.
Missing or duplicated patient data can lead to physicians making incorrect treatment decisions for heart failure patients based on inaccurate pulmonary artery pressure readings. While no injuries have been reported, the firm has received complaints regarding these data errors.
Includes 11 total units located at Treating or Consulting Clinics that have no serial number recorded.
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.
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Sources: FDA iRES · Raw API Response
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