FDA 483 - Boston Scientific Corporation - April 07, 2025

An FDA inspection of Boston Scientific Corporation in Saint Paul, MN, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately establish procedures for process monitoring, nonconforming product control, corrective and preventive actions, risk analysis, design verification, acceptance activities, complaint handling, and statistical techniques. These issues involved critical medical devices such as implantable pacemakers, cardiac cryoablation systems, and pulsed field ablation systems, with some deficiencies linked to patient deaths and serious injuries.