Guidant Recalls Defibrillators That are Implanted in 50,000 People
Today Guidant Corp. announced that it is voluntarily recalling cardiac defibrillators, which about 50,000 people around the world have implanted in them.
The defibrillators have flaws that can lead to their malfunction, which can lead to the death of the person who has it implanted inside of them. At least two people with the defibrillators have died so far.
Guidant, which is based in Indianapolis, said that it is advising doctors about the safety of three models of defibrillators. There have been 45 cases in which the devices have failed.
The devices in question include :
“Patient safety is paramount and our highest priority,” stated Guidant President and CEO Ronald W. Dollens. “As a leading manufacturer of lifesaving technology, Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcomes and limit adverse events to patients.”
“The purpose of the company’s recent communications is to share information with physicians and patients about problems in a small subset of Guidant devices,” continued Dollens. “We will work with physicians as they decide how best to treat their patients.”
Dollens added, “Guidant is committed to establishing industry guidelines and processes to determine when, how and under what circumstances adverse events should be communicated to doctors and patients. Guidant hopes to work with FDA, other regulatory agencies and physicians to convene a panel to assist the medical device industry in establishing clear guidelines.”
MarketWatch reports that Guidant shares fell 92 cents, or 1.3%, to $72.74 in recent trading. Guidant is being acquired by Johnson & Johnson, which was up18 cents to $66.48 in recent action.