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Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

Families and patients are filing lawsuits against device maker Medtronic over its insulin pump, which they claim is defective and has resulted in fatal insulin overdoses. One pump was among over 400,000 recalled by the company in 2019 due to a fault that could lead to an over or under delivery of insulin, potentially causing severe harm or death. In response to the suits, Medtronic has denied its pump caused any deaths and requested a court motion for summary judgment.

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