FDA Calls Out St. Jude for Downplaying Defibrillator Problems

According to a warning letter sent by the FDA to Abbott Laboratories (owner of medical device manufacturer St. Jude Medical, responsible for 400,000 implantable defibrillators), reported that St. Jude downplayed defibrillator battery problems and sold defective devices for years before issuing a recall in October 2016. The defect stems from the lithium-based batteries that power the defibrillators being prone to lithium build-up, or “clusters,” which can cause premature battery failure. In the warning letter, the FDA noted that St. Jude had not taken enough action to remedy the faulty battery issues that led to the recall, and required St. Jude to provide a plan for correcting the problems within 15 days.

If you or a loved one received a St. Jude Medical Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator implant and experienced complications, please call us at (888)-984-7988.

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