Corporate Compliance

Boston Scientific recalls Taxus Express2 stents

Compliance Monitor, July 7, 2004

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Boston Scientific Corp. announced July 2 it will recall 200 of its recently approved drug-coated coronary stents because of a malfunction that resulted in at least one death.

The medical-equipment manufacturer said there are elements in the delivery catheters that have the potential to block balloon deflation during a coronary angioplasty procedure.

It blamed the problem on a manufacturing defect that has since been fixed.

Boston Scientific's Taxus Express2 stent is coated with slow-release drugs to prevent scar tissue from forming new blockages after surgery.

The stents were shipped to 99 U.S. hospitals.

The company said it reported one death and 16 serious injuries from such deflation failures to the Food and Drug Administration.

To read more, click here.



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