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Vascular Solutions Inc. and its CEO Charged with Selling Unapproved Medical Devices and Conspiring to Defraud the United States

An indictment was filed today charging Vascular Solutions Inc. (VSI) and its chief executive officer, Howard Root, with selling medical devices without U.S. Food and Drug Administration (FDA) approval and conspiring to defraud the United States by concealing the illegal sales activity. The announcement was made today by Acting Assistant Attorney General Joyce R. Branda for the U.S. Department of Justice's Civil Division, U.S. Attorney Robert Pitman for the Western District of Texas and Special Agent in Charge Antoinette V. Henry of the U.S. Food and Drug Administration (FDA)'s Office of Criminal Investigations, Metro Washington Field Office. The devices at issue are from VSI's "Vari-Lase" product line, a system designed to treat varicose veins by burning or "ablating" them with laser energy.

Read more on www.justice.gov

Action Details

  • Date:November 13, 2014
  • Agency:U.S. Department of Justice
  • Enforcement Types:
    • Criminal and Civil Actions

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