In June of 2005, the U.S. Food and Drug Administration issued a nationwide recall of certain implantable defibrillators produced by Guidant Corp., an Indianapolis-based manufacturer of health care products. The recalled defibrillators were implanted in nearly 50,000 patients nationwide. The FDA notice alerts medical professionals and consumers that the defective devices can short circuit without warning, nullifying their effectiveness. The recalled devices were manufactured between April of 2002 and August of 2004.
The types of defibrillators recalled were implanted in patients suffering from life-threatening heart arrhythmia, or an abnormal rhythm. The devices are intended to deliver an electrical shock to the heart during an arrhythmic episode to restore normal heart rhythm. The recalled devices are subject to mechanical failures that cause the defibrillator to be unable to deliver an electrical shock when the patient’s life may depend on it. At least two deaths associated with this malfunction have been reported to the FDA.
Daniel Schultz, MD, Director of FDA’s Center for Devices and Radiological Health, stated that “[The FDA] want[s] to ensure that all patients who may be affected by this problem are notified and seek appropriate medical advice from their physicians.” However, the FDA has not commented on whether individual patients who have one of the Guidant defibrillators should have it removed and replaced, instead deferring to patients’ physicians on a case-by-case basis. The FDA advises patients who believe they may have a defective defibrillator to contact their physician.
Defective models include to following:
- Prizm 2 DR
- Contak Renewal
- Contak Renewal 2
- Ventak Prizm AVT
- Vitality AVT
- Renewal 3 AVT
- Renewal 4 AVT ICDs
Defective devices have remained inside some patients for more than three years despite the manufacturer’s knowledge that the defibrillators could lead to discomfort and death. Guidant is also accused of keeping cardiologists and other healthcare professionals oblivious to the devices’ dangers, thus facilitating more and more people to be put at risk. Not until the sudden and unexpected death of a 21 year-old defibrillator patient in March of 2005 did Guidant disclose that it knew about 25 other similar cases. Meanwhile, the company reported $1.8 billion in revenues over 2004.