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Defibrillator Recall Defective Products
Guidant Defibrillator Recall – Overview/Update
Several models (approximately 20) of Guidant defibrillators have been recalled by the company following reports of failure and death. In 2005, two recipients of flawed heart defibrillators died from the devices – one model was a Prizm 2 and the other was a Contak Renewal device – both a part of the Class I recall (explained below). The Contak 3 has been taken off of the Guidant recall list as a switch component was recently replaced. Defibrillators which are implanted surgically under the collarbone shock erratic heart beats back into beating normally. The reported malfunctions include problems with short circuiting or faulty switches (about 29,000) and a computer memory error (about 21,000) that can affect therapy. Guidant said its devices had failed at least 45 times.
Guidant (now owned by Boston Scientific) has been under the spotlight for the way it disclosed product problems with its heart device units. Purportedly, in Guidant’s annual report to the FDA in February, the company informed the regulators that one of its model defibrillators short-circulated at the rate of about one a month. Subsequently, Guidant Corporation in June and July of 2005 issued a series of safety advisories to health care providers that many implantable defibrillators models malfunctioned and recalled several units. Also in June of 2005, the FDA issued an alert about one particular model, and updated it in July 2005, classifying three models of the company’s defibrillators as a Class 1 recall. A Class 1 recall is the most serious type of notification, which means that there is a reasonable probability that if the device malfunctions, cardiac users could suffer death or serious injury.
The three units in the Class 1 recall were: Ventak Prizm 2DR (model 1861); Contak Renewal (model H135); and Contak Renewal 2 (model H155). The FDA also gave Class II status to eight other models of Guidant defibrillators; Class II notification meant a user could suffer temporary or medically reversible injuries if the device failed. Guidant alleges the defects can be detected and fixed non-invasively by reprogramming at the doctor’s office. As of August 2006, Guidant has recalled 136,200 defibrillators since June of 2005.
On April 10, 2007, Guidant issued a new recall of 73,000 devices due to 19 incidences of premature battery depletion. At the time of the recall, no serious injuries or deaths were reported. The affected devices distributed in the US include the Contak Renewal 3 HE CRT-Ds (Models H177 and H179); Contak Renewal 3 CRT-Ds (Models H170 and H175); Vitality 2 DR ICDs (T165); Vitality 2 VR ICDs (T175); Vitality AVT ICDs (A155); Vitality DS DR ICDs (T125); and Vitality EL DR ICDs (T135).
As of July 2008, federal regulators approved new wireless technology that allows doctors to keep an eye on patients with implanted heart devices. Cardiac patients who have received a defibrillator shock should see their health care professional.
If you or someone you love has been injured by a Guidant defibrillator, or suffered emotional injuries due to malfunctioning defibrillators, you may want to consult a product liability lawyer who specializes in medical device or product liability law.
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