Cases,
Laws, Medical News
Case
Status
Print
this pageGuidant Warns Doctors Not to Implant Its Heart Devices
WASHINGTON, DC — July 1, 2005 — Guidant Corporation told doctors last week not to implant its heart devices or defibrillators because of serious safety issues (Press Release, June 24, 2005). A defibrillator normally provides a shock to the heart that restores normal rhythm. However, some models of Guidant defibrillators do not function properly because a magnetic switch can become stuck in the “off” position. In some cases, the error could prove fatal when heart rhythm is not corrected.
Over 44,000 patients have already been implanted with these Guidant defibrillators. The flawed devices are: CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF.
A History of Flawed Guidant Products
On June 17, Guidant recalled other defibrillator models: PRIZM 2 DR, Model 1861; CONTAK RENEWAL, Model H135;, and CONTAK RENEWAL 2, Model H155. The defibrillators can develop short circuits so that they are no longer able to produce a shock to correct irregular heart rhythms (FDA News, June 17, 2005). Other models (PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT) were recalled due to a memory error that affects performance.
Guidant may have known for at least three years that some defibrillator models were defective, according to the New York Times (June 25, 2005). A securities fraud lawsuit filed in federal court in Indianapolis, IL, charges that Guidant covered up problems with its heart defibrillators in order to inflate stock prices.
What Should I Do About My Guidant Defibrillator?
Guidant now urges patients to contact their doctors or go to the hospital emergency room immediately if they hear warning tones from their defibrillators. The Food and Drug Administration (FDA) warns patients to immediately contact their doctors if they feel an electrical shock from the devices.
The FDA stopped short of saying whether Guidant defibrillators should be removed and replaced, which is a decision to be made by doctors and their patients. Doctors consider the possibility that the defibrillator may fail as well as the risks involved with replacing the device, including injury and infection.
Obtaining More Information About Guidant Defibrillators
For a list of questions to ask your doctor about Guidant and other defibrillator recalls, see the web site of the Heart Rhythm Society, an association of heart specialists. See the Cleveland Heart Clinic web site for an explanation of how defibrillators work.
Brayton Purcell is concerned about defective heart defibrillators and other unsafe medical devices. 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.