Three former executives at Spectranetics were indicted for apparently illegally importing unapproved medical devices, according to the office of Colorado U.S. Attorney John Walsh.
George John Schulte, former CEO of the Colorado Springs-based company; Obinna Adhigije, former vice president of business development; and Trung Pham, former business development manager; were named in the indictment.
Hernan Ricarute, a representative of a Florida company contracted by Spectranetics to identify potential business clients for the company, was also named in the indictment.
The men are accused of making false statements, conspiracy, receipt of illegal imports, sales of adulterated and misbranded medical devices and other offenses.
“Today’s indictment sends a clear message that the FDA will investigate those individuals who jeopardize the public health by importing and distributing unapproved and uncleared medical devices, “said Patrick J. Holland, special agent in charge of FDA’s Office of Criminal Investigations in Kansas City.
The company settled a Justice Department case in December 2009 for $5 million. The suit accused the company of illegally importing unapproved medical devices. Spectranetics was not named in Monday’s indictment.