St. Jude Medical ICD Recall

defibrillator with medical device

Have you or a loved one been injured by an implanted defibrillator from St. Jude Medical due to premature battery depletion?

(The St. Jude defibrillator is not related in any way to St Jude Children’s Research Hospital in Memphis, TN)

The FDA has issued a Class 1 recall, the most serious type of recall, on these devices because of the danger of serious injury or death. Rapid battery failure due to deposits of lithium forming within the battery and triggering a short circuit can cause these pacemaker devices to run out of energy before the patient is aware of the problem or has a chance to have it replaced.

Which St. Jude Medical devices are affected?

The recall covers Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) manufactured and marketed by St. Jude Medical. Here is a list of the devices covered by the FDA recall:

  • the heart of human and artificial cardiac pacemaker, vector illustrationFortify® VR
  • Fortify® ST VR
  • Fortify Assura™ VR
  • Fortify Assura™ ST VR
  • Fortify® DR
  • Fortify® ST DR
  • Fortify Assura™ DR
  • Fortify Assura™ ST DR
  • Unify®
  • Unify Quadra™
  • Unify Assura™
  • Quadra Assura™
  • Quadra Assura MP™

Almost 400,000 of these cardiac devices were manufactured by St. Jude Medical from January 2010 to May 2015 and feature a faulty design that can short circuit and cause total battery failure in as short a period as 24 hours.

What are the possible symptoms of premature battery depletion?

The devices were designed to last approximately 7 years following implantation before needing replacement, but this issue is causing that time period to be reduced unexpectedly if the battery problem surfaces, sometimes with devastating effect. Symptoms may include:

  • Feeling lightheaded
  • Dizziness
  • Loss of consciousness

  • Chest pain
  • Shortness of breath
  • Death

You may be owed damages. Contact Our Medical Device Attorneys for More Information.

The law office of Bubalo Law PLC can assist in determining if you have one of the St. Jude Medical ICD or CRT-D devices covered by the recall and what your legal options are. We can also help you learn if you are owed compensation due to one of the medical devices and the complications caused by the need to deal with the situation. We urge you to contact us now and let us do a FREE case review.

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