483
Boston Scientific CorporationBoston Scientific Corporation – FDA 483, Jan 11, 2017
Record Details
An FDA inspection of Boston Scientific Corporation in Fremont, CA, revealed significant quality system deficiencies related to their Angiolet Thrombectomy System. The firm failed to report device corrections to the FDA, adequately establish corrective and preventive action procedures, and properly investigate complaints regarding device malfunctions. These issues primarily concerned sticking foot pedals, indicating a lack of robust quality control and potential risks to patient safety.
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ID · 941df74c-8d96-4cf9-9b26-0fe623c650e1
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