Edwards Lifesciences, LLC has recalled over 339,000 pressure monitoring kits and sensors, including Acumen IQ, FloTrac, and TruWave brands, because of potential difficulties during the flushing and setup process. This defect can prevent the intravascular pressure transducer from being prepared correctly for medical use. These devices were distributed across the United States and multiple international locations for use in professional healthcare settings.
If the pressure monitoring kit cannot be flushed properly, it may result in a delay in critical patient monitoring or improper function of the sensor during medical procedures. This poses a risk of harm to patients who require accurate and continuous intravascular pressure monitoring.
Healthcare provider or manufacturer coordination
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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