What led to the extensive Guidant defibrillator recall?
The company received reports of over 45 device malfunctions and two linked deaths. An estimated 29,000 distributed devices contained defective insulation that did not properly protect the wires. If the insulation deteriorated, the potential for short-circuiting was great. The second phase of the recall included additional models that contained programming errors, resulting in failure. What restitution has Guidant made? The company offered to provide free defibrillator replacements. What type of defibrillator do I have? You should have been given ID cards for your device. If you are unsure, ask your doctor. He or she can provide you with the medical make and model and device information. If I have a recalled Guidant model, what happens next? You and your doctor will discuss how best to proceed. The FDA recommends that your doctor review your individual case to determine whether or not a removal and implantation of another model is the best option. As any surgery carries a risk of infect
