FDA 483 - AngioDynamics, Inc. - June 25, 2021

AngioDynamics, Inc. DBA Navilyst Medical Inc., a medical device manufacturer in Glens Falls, NY, was cited for two significant issues during an FDA inspection. These included inadequate corrective and preventive actions for their Solero MTA Systems, specifically concerning software updates and verification of effectiveness. Additionally, the firm failed to report a recall of their Xcela Picc with PASV Valve Technology Power Injectable PICC to the FDA, despite the device presenting a risk to health.