In October, 2016, The U.S. Food and Drug Administration (FDA) announced a recall of certain St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). In the defective defibrillators, the batteries can run down much sooner than expected and without sufficient warning. If the battery dies, your defibrillator cannot deliver a life-saving shock or heart pacing, and you can die.
St. Jude Defibrillator Recall
This is a class 1 recall, the most serious type of recall, issued when a defect can cause serious injury or death. 251,346 devices are being recalled. The affected devices were manufactured from January 2010 to May 2015 and distributed from February 2010 to October 2016. The following products are recalled:
- Fortify Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
- Unify Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
- Assura Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
The FDA has listed the exact model numbers in its recall notice.
The Danger
ICDs and CRT-Ds are devices that are implanted in the chest. The help control heart rate in patients with heart rhythm disorders by delivering electric shocks to the heart. When the devices are working normally they alert the patient several months before the battery runs down so the batteries can be replaced. In the defective devices, the batteries are depleted rapidly and warning is not given in time.
According to the FDA, there were two deaths reported, as a result of the defect, by the time the recall was issued.
If you or someone you love has been injured by a defective implanted defibrillator or has a recalled St. Jude defibrillator, please talk to an experienced defective medical device attorney right away to learn more about your rights and potential compensation.
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