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Manufacturer Agrees to Pay $74 Million

By Janice G. Inman

Natick, MA-based Boston Scientific Corp. has agreed to pay $74 million to the United States to resolve an ongoing investigation concerning its 1998 distribution and subsequent recall of one of its coronary stent delivery systems. In agreeing to the settlement, the company did not admit to any wrongdoing.

The complaint, filed in federal district court, alleged that Boston Scientific commercially distributed premounted coronary stents that had a manufacturing defect that resulted in random failures of the balloons used to deploy the stents; that the company failed to identify and segregate the defective devices to ensure that they were not distributed commercially; and that the company failed to establish proper internal procedures to identify the causes of the defects.

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