FDA grants approval to Guidant Corporation to relaunch its Contak Renewal 3 implantable defibrillator previously recalled due to a faulty switch
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Guidant Corporation announced August 1, 2005, that it has received approval from the U.S. Food and Drug Administration to relaunch its best-selling Contak Renewal 3 implantable defibrillator. The Contak Renewal 3 is currently implanted in about 40,000 patients worldwide an was previously recalled due to a faulty switch that could short-circuit, causing shocks to the patient as well as equipment failure that could render a patient unprotected from a potential heart attack.
The relaunched medical device will have a new switch that has been approved by the FDA. The company has faced intense criticism due to its failure to warn patients and doctors of defects found in its medical devices despite deaths attributed to them.
Source: “Guidant relaunches heart device,” Associated Press, August 2, 2005.

