BOSTON – Boston Scientific Corp. (BSX) has agreed to pay $74 million to settle a civil complaint over the medical-device maker's 1998 recall of coronary stents.
The company did not admit liability as part of the agreement announced Friday afternoon by U.S. Attorney Michael J. Sullivan.
"This case represents a failure by Boston Scientific to take the most appropriate steps in a timely manner to ensure that the devices it was distributing to hospitals nationwide performed properly," Sullivan said in a statement.
The Natick, Mass.-based company disclosed in 1998 that it was the target of a grand jury probe of a recall earlier that year of their coronary stents (search), which are metal-mesh devices that keep arteries working after surgery to clear blockages.
Boston Scientific, which has said it acted responsibly, recalled the stents because the tiny balloons used to position the stents sometimes leaked, creating a risk that a deflated balloon in the bloodstream could lead to medical complications.
Neither the company nor the Justice Department (search) has offered details on what the government was investigating about the recall, which involves stents Boston Scientific no longer markets.