Boston Scientific Express Stent
The Boston Scientific Express stent system consists of a stent, a small mesh metal tube, which is mounted on a balloon catheter. The stent is inserted into a blood vessel and advanced within the vessel to the narrowed section of the coronary artery. When the stent is correctly positioned, the balloon is inflated, causing the stent to expand. Expansion of the stent pushes plaque in the blood vessel aside, opening the narrowed section of the artery and restoring normal blow flow to the heart. The balloon on the stent delivery catheter is then deflated and the delivery catheter is removed from the patient. The stent remains permanently implanted supporting the newly opened section of the vessel.
Class I recalls are the most action the FDA can take against a product. The Boston Scientific Express stent underwent a Class I recall after flawed characteristics in the design of the stent system caused difficulties with balloon deflation and impeded removal of the balloon.
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