BOSTON SCIENTIFIC TO PAY $74 MILLION IN RECALL PROBE
Boston Scientific will pay $74 million to settle a civil complaint by the Department of Justice regarding the agency's investigation of the company's 1998 voluntary recall of the NIR ON Ranger with SOX stent system.
The probe began after Boston Scientific recalled a stent system that injured 26 people and was possibly tied to one death. It was accused of illegally continuing to make and sell systems for implanting stents even after learning that a significant percentage of them were defective. The FDA also cited the company for violating rules by making a manufacturing change without alerting the agency.
The company recalled the stents because tiny balloons used to position them sometimes leaked, creating a risk that a deflated balloon in the bloodstream could lead to medical complications. The company did not admit any wrongdoing as part of the settlement.