Boston Scientific Taxus Stent
Boston Scientific Taxus stent is one of Boston Scientific's highest selling products. Boston Scientific has evolved into one of the largest coronary stent manufacturers in the world.
The Boston Scientific Taxus stent system consists of a small metal tube which is mounted on a balloon catheter. It is inserted into a blood vessel and advanced within the vessel to the narrowed section of the coronary artery. When the Boston Scientific Taxus stent is correctly positioned, the balloon is inflated, causing the stent to expand. Expansion of the stent pushes the plaque aside, opening the narrowed section of the artery restoring normal blood flow to the heart. The balloon on the Boston Scientific Taxus stent delivery catheter is then deflated and the delivery catheter is removed from the patient. The Boston Scientific Taxus stent remains permanently implanted to support the newly opened section of the vessel. A drug, paclitaxel, is slowly released into the artery wall around the Boston Scientific Taxus stent. The drug reduces the chance of vessel narrowing again in the stented segment of the vessel.
Characteristics in the design of these two lots resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement. Impeded balloon deflation can result in significant patient complications, including emergency coronary artery bypass graft surgery and death. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death. The Boston Scientific Taxus Stent is subject to a Class I recall.
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