About 85,000 Taxus stents are being recalled voluntarily by Boston Scientific because of possible defects. Of the 42 complaints received, 30 systems showed actual performance flaws generally thought to be the result of excess heat being applied during the laser welding stage during the manufacture of the product; 200 Taxus stents were recalled earlier this month.
In a meeting with the FDA in early August, Boston Scientific reported finding a slightly higher risk of blood clotting in patients with the new drug-coated stents compared with bare-metal versions and at the World Cardiology Congress in Barcelona, Spain, recent study findings were released indicating a higher risk of rare instances of potentially fatal blood clots. The September 7, 2006 edition of the Wall Street Jounal reported on the study.
While bare-metal stents allow cells to naturally grow to cover the stent after surgery the drug-coated versions like Taxus can prevent tissue growth which helps prevent blockages but leaves exposed metal that can act as a magnet for clots.