FDA 483 - Vascular Solutions, Inc. - October 10, 2025

Vascular Solutions, LLC, a medical device sponsor in Maple Grove, MN, was cited for significant deficiencies in its oversight of an investigational study. Observations included failures to ensure proper monitoring and IRB review, specifically regarding Data Safety Monitoring Board (DSMB) meeting frequency and the handling of adverse events. Additionally, the firm failed to submit required progress reports to all reviewing IRBs and did not maintain complete records for final reports to IRBs upon study completion.