In July 2004, Boston Scientific Corporation announced a voluntarily worldwide recall of its TAXUS Express 2 Paclitaxel-Eluting Coronary Stent Systems and Express 2 Coronary Stent Systems (bare metal stents). The recalls involves approximately 85,000 TAXUS stent systems and approximately 11,000 Express 2 stent systems. The recall does not affect the Express SD and LD biliary stent systems.
The Company issued the recall after receiving reports that patients had been injured during the removal of a tiny balloon placed inside the artery to inflate the stent during surgery.
The company says the problem is due to characteristics in the delivery catheters, which have the potential to impede balloon deflation during a coronary angioplasty procedure.
Though rare, the impeded balloon deflation can result in significant patient complications, including coronary artery bypass graft surgery and death. The Company has confirmed reports of one death and 18 serious injuries associated with balloon deflation for the TAXUS stent system, and two deaths and 25 serious injuries associated with balloon deflation in the Express 2 (bare metal) stent system.
The company announced that the recall does not affect patients who have already received these stents, because the problem is with the delivery system and occurs at the time of insertion, not afterward.
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