Class 1 Recall: Boston Scientific Express2TM (bare metal) Coronary StentJul 23, 2004 | www.fda.org
The Express2â„¢ stent system consists of a stent (small 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 the plaque aside, opening the narrowed section of the artery 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.
Reason for Recall: Characteristics in the design of this stent system 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. Hospitals should immediately discontinue use of any affected units. 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.