Guidant Defibrillators Can Leave You Heartbroken
Guidant has admitted that many of its heart devices known as defibrillators pose serious safety issues. A defibrillator normally provides a shock to the heart that restores natural heart rhythm. However, Guidant defibrillators may leave you sadly out of sync, and the result may be life–threatening.
Urgent “Class 1” Recall of Certain Guidant Defibrillators
The Food and Drug Administration (FDA) includes the Guidant defibrillators listed below in a “Class 1” recall, the most urgent recall category. If a Class 1 device does not function properly, it can cause severe health problems or even death. These Guidant defibrillators may develop a short circuit so that the proper shock is not delivered to the heart:
- PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002;
- CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004; and
- CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
There are 42,000 affected Guidant defibrillators in the Class 1 category, 20,600 of which are still implanted. At least two have caused deaths, according to the FDA.
Other Flawed Guidant Defibrillators
Some newer Guidant defibrillator models have a switch that can stick in the “off” position, making them unable to treat abnormally fast heart rhythms. Over 46,000 patients have already been implanted with these devices. Because the flawed Guidant devices can cause health problems in some patients, they are part of a Class 2 recall. Doctors have been told not to continue implanting these Guidant models:
- CONTAK RENEWAL 3;
- CONTAK RENEWAL 4;
- RENEWAL 3 AVT;
- RENEWAL 4 AVT and
- RENEWAL RF.
Guidant recalled other defibrillator models because of a memory error that may limit heart therapy. The devices may be reprogrammed, according to Guidant. They are: VENTAK PRIZM AVT, VITALITY AVT AND RENEWAL AVT.
What Questions Should I Ask My Doctor?
If you have a Guidant defibrillator, you may want to find out the model name and number from your doctor. If you feel a shock, the FDA advises you to contact your doctor as soon as possible. If you hear a “beeping” sound from your device, go immediately to your doctor or the emergency room because this could be a sign of malfunction.
The FDA did not issue advice about whether Guidant defibrillators should be removed and replaced. This is a tough decision to be made by you and your doctor. Doctors consider the possibility that the defibrillator may fail as well as the risks involved with replacing it, including injury and infection.
Brayton Purcell is currently evaluating claims about defective defibrillators. Please feel free to contact us if you or a loved one has been injured and would like information about your legal options. We have been handling medically–related consumer cases for over 20 years, and have represented hundreds of clients against medical device manufacturers.
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