Medtronic MiniMed, Inc. is recalling approximately 114,758 Guardian 4 Glucose Sensors because a manufacturing defect caused the protective coating on some sensors to be thinner than required. This defect can lead to inaccurate sensor glucose readings or a total loss of sensor function. If the sensor provides incorrect data to an insulin pump, it may cause the system to deliver too much or too little insulin, potentially leading to serious health complications. Consumers should verify if they have affected sensors by checking the model and lot numbers listed below.
A thin sensor coating can cause the device to report incorrect glucose levels, leading to the over-delivery or under-delivery of insulin. This poses a significant risk of hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar), which can be life-threatening if not properly managed.
Manufacturer-initiated recall due to non-conforming layer thickness.
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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