on Friday said it would pay $74 million to settle a Justice Department investigation into the company's 1998 voluntary recall of a coronary stent.
The settlement concludes the department's criminal investigation of the company's behavior. Boston Scientific said no charges were brought against the company or any employees.
"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," said Michael Sullivan, U.S. Attorney for the District of Massachusetts at a press conference Friday. The investigation, which started in November 1998, focused on the shipment, sale and eventual recall of the stent delivery system.
"We are very pleased that a six-year investigation into the 1998 recall of a now-obsolete product and related events has ended with no charges against the company or any employee," said Jim Tobin, Boston Scientific's president and CEO, in a prepared statement.
"The settlement involves no admission of any wrongdoing," Tobin added. "We believe that Boston Scientific and its employees acted legally, responsibly and appropriately at all times. We elected to settle this lingering matter so we could put it behind us and devote our full energies to developing our life-saving medical technologies."
In October 1998, the company recalled the NIR ON Ranger with SOX stent system because of problems in the system that delivered the stent. At the time, a notice from the company and the Food and Drug Administration said 26 injuries and one death had been reported in relation to the stent system.
Coronary stents are metal tubes inserted into arteries to keep blood flowing and reduce the risk of arteries reclogging after dangerous plaque has been cleared away. Stent delivery systems are attached to catheters, which a physician manipulates to the clogged part of the artery. At the tip of the catheter is a small, uninflated balloon. The doctor inflates the balloon to clear the obstruction, then deflates the balloon, leaves the stent as a conduit for the blood and withdraws the catheter.
The problem with the 1998 stent was the rupturing of the balloon, "resulting in incomplete stent deployment and/or stent migration; and difficulty deflating and removing the stent delivery system," the warning letter said.
The 1998 stent is unrelated to the company's Taxus drug-coated stent which enables a chemical to be released periodically into the vessels to reduce the risk of the artery reclogging.
Last year, Boston Scientific, which is based in Natick, Mass., recalled 88,000 Taxus stents and 11,000 uncoated stents because of balloon-inflation problems.