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  • Regulatory NewsRegulatory News

    Boston Scientific Ordered to Pay Surgical Costs for Faulty Pacemakers

    A prominent European court has ruled that Boston Scientific’s German branch is responsible for paying the surgical costs associated with replacing faulty implantable devices made by one of the company’s subsidiaries. In 2005, Guidant Corporation – which was acquired by Boston Scientific in 2006 – informed doctors it had identified potentially faulty components in three of its implantable products, two pacemakers and an implantable cardioverter defibrillator. Main Proc...
  • Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions

    The medical device industry is being shaken by a series of issues involving St. Jude Medical's defibrillator leads, reports The New York Times , leading to serious questions about transparency, adequate regulation and patient safety. The medical device leads have been implicated in a series of serious adverse events, including some where the wire contained inside the defibrillator leads have failed, leaving the wires to become exposed. The Times reports two other med...