FDA 483 - Boston Scientific Neuromodulation Corporation - April 08, 2026

Boston Scientific Neuromodulation Corporation received a Form 483 citing significant deficiencies across its quality management system, particularly in risk management, design controls, complaint handling, and Medical Device Reporting. The firm failed to adequately assess and mitigate risks for its Deep Brain Stimulation (DBS) and Spinal Cord Stimulation (SCS) devices, leading to issues like underestimating harm severity, ineffective corrective actions, and delayed investigations into serious patient events. These systemic failures resulted in the distribution of potentially defective products and a lack of timely reporting of adverse events.