August 2, 2005
The Food and Drug Administration has given permission to Guidant Corp. to resume sales of its cardiac defibrillator, five weeks after the FDA ordered a recall because of a faulty switch. The electronic devices are supposed to deliver a shock to the heart when they detect an abnormal rhythm.
Guidant has recalled 88,000 defibrillators and 28,000 pacemakers this summer because of potential problems. The company blames the recalls on "small, residual imperfections."
Some business analysts say it may take some time before Guidant regains the full confidence of the heart patients who use their product. The FDA says the recalled device failed in at least 26 cases and is suspected in two deaths, including a college student who died in March.
In May, Guidant admitted that it knew about the defect for three years but had not told doctors about it. The company said it changed the design in 2002 to remedy the problem. The company contends it has followed FDA guidelines in reporting problems to the agency.
Guidant notified doctors of the problem after it became aware that The New York Times was about to publish a story about the problems with the device.
The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia, or abnormal rhythm. The devices deliver an electrical shock to the heart to restore normal heart rhythm.
