FDA 483 - Boston Scientific Corporation - January 11, 2017

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.