Boston Scientific Stent Problems Continued After RecallJul 13, 2005 | Boston Business Journal
The U.S. Food and Drug Administration reported more than 130 cases of deflation problems or other difficulties with the company's stent balloons between Oct. 1 2004 and April 1, the Wall Street Journal reported, based on its review of the agency's data.
An FDA spokeswoman told the newspaper that a preliminary evaluation of the data was consistent with its expectations and not connected to the manufacturing flaw involved with last year's recall.
Boston Scientific said it fixed the manufacturing flaw and has made progress in reducing complaints about its stents.
Last summer, the Natick, Mass.-based company (NYSE: BSX) recalled more than 99,000 stent systems after at least three deaths and a number of injuries when the stent balloons failed to inflate.
A stent system is used to clear a blocked pathway in an artery and the balloon portion is used to expand the artery so a stent can be inserted.