• As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • 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...