The following recall information pertains to the Guidant Corporation’s defibrillator models known as the PRIZM® 2 and CONTAK RENEWAL® brands of defibrillator. These models of defibrillator are known as implantable cardioverter defibrillators (ICDs), as they are physically implanted in the patient in order to provide an electric shock to the heart, in an effort to normalize the heartbeat, when the patient is experiencing an irregular heartbeat episode. Due to a number of medical device malfunctions that have led to severe injury and death, Guidant Corporation, an Indianapolis, Indiana based medical device manufacturer, has recalled these specific cardioverter defibrillator models. It was discovered by Guidant Corp. that, when the patient was in most critical need of their defibrillator, such as for example when the patient was experiencing an irregular and fast heartbeat, Guidant Corp. discovered that a number of their defibrillator models were known to frequently malfunction by short-circuiting, and in doing so could seriously impact the survival of the patient experiencing such a severe irregular heartbeat episode. It is understood that when Guidant Corp. first learned about the high potential for failure by short-circuiting evident in a large number of their cardiac defibrillator models, they did not immediately release such critical medical information. It has been made public that, with the knowledge that their medical device could short-circuit when proper functionality was critical for patient survival, Guidant Corp., for a period of three years, informed neither doctors nor patients about their defective defibrillators. As of October 2005, the FDA has made a note that, as regards Guidant Corp.’s Contak Renewal® and Renewal® 2 cardioverter defibrillators, there have been 21 reported cases of defibrillator failures and 3 deaths due to defective defibrillator short-circuit problems worldwide.
According to the FDA, Guidant Corp.’s recall pertains to the following cardioverter defibrillator models.
The following models of cardiac defibrillators have been categorized as having the potential to fail during a critical moment of need, and thus, Guidant Corp., in an effort to prevent further injury and death, has released a warning and recall for the following defibrillator models:
The medical device and defibrillator community was put on alert about the possibility for certain models of Guidant Corp.’s defibrillators to fail during the patient’s critical moment of need, when a 21-year-old college student from Minnesota died due to a failure in his VENTAK PRIZM® 2 DR, Model 1861 cardioverter defibrillator. Critical corrections to this specific model of cardioverter defibrillator were made in April and November 2002. It is understood that the college student received his defibrillator implant in 2001. Furthermore, event after essential modifications were made to the VENTAK PRIZM® 2 DR, Model 1861 cardioverter defibrillator, Guidant Corp. continued to distribute cardioverter defibrillators made before April and November 2002, the defibrillators that did not have the critical corrections.
The U.S. Food and Drug Administration has given the counsel that patients with Guidant heart defibrillators immediately make an appointment to meet with their doctor, especially if the patient is unsure about whether or not their defibrillator is one of the models included in Guidant’s defibrillator recall. Another recommendation has been made that heart defibrillator patients seek the advice of an electrophysiologist.
If you or someone you know has experienced an undue amount of harm, injury, and suffering as a result of Guidant Corporation’s negligence to properly inform doctors and patients about certain defective defibrillator models, you may be entitled to receive compensation. If you would like to seek retribution for experiences with a defective Guidant Corp. defibrillator, attorneys at Carey Danis & Lowe can provide experienced legal counsel. Contact an attorney at Carey Danis & Lowe about filing a class action lawsuit today at 800.721.2519. If you are a victim of Guidant Corp.’s egregious negligence, our attorneys can assist you in seeking the justice you deserve.