Guidant Defibrillator is a type of ICD or Implantable Cardioverter Defibrillator which has been designed for the regulation of the rates of the heart beats. This tiny defiective device is basically placed into the body to keep the vigilance at the heart rates and functionalities of the heart. It is very pathetic news that these Guidant Defibrillators are not superb in quality. They have not performed well. So, FDA was under obligation to recall these devices for the poor functionality. Approximately 73000 cardiac defibrillators have been removed from the market. These devices faced the technical faults with defective capacitors.
Due to non-workable capacitors, these sophisticated devices experienced battery depletion, and irregularity to send the impulses. The durability of these capacitors was also very low. The Guidant Defibrillator recall includes Guidant Prizm 2 DR, Guidant Contak Renewal and Contak Renewal 2, Guidant Renewal 3 AVT and Renewal 4 AVT ICDs inclusive of Guidant Vitality AVT and so on. After much revision and check up, the FDA officials directed the company not to market all these defective devices which can cause untimely death and physical disorders. However, in 2005, Guidant confessed that at least three patients died due to the battery depletion of the defibrillators. For this reason, FDA decided to establish a fact finding committee to issue a show-cause notice to the company seeking for the explanation regarding the defective mechanism in the computerized device. After that, Guidant faced a number of investigations done by FDA. As per the reports given by the experts of the FDA, Contak Renewal and Renewal 2 electronic apparatuses were thoroughly check and these devices were later declared as defective and non-workable ICD.
After much research and probing, it was found that there was lot of technical problems in the mechanism of these devices. For instance, these devices had the low graded computerized memory and rigidity in re-circulating the current or impulses properly through this ICD. A number of lawsuits were filed against the company as they marketed very low quality Guidant Defibrillators. The manufacturer was legally bound to provide the full compensatory money to the victims after getting the final verdict from the court. In an official press release, on behalf of the Guidant Defibrillator company, it was confessed that three persons expired due to the implantation of these devices into the body. Then this company received numerous complaints about the poor performance of these defibrillators. Therefore, experts advise the general persons not to opt for these defective Cardioverter Defibrillators which will be destructive and harmful to the body.
Thus far two patients using one of the recalled defibrillators has
died and an additional 45 cases have been documentated where
the device has failed. The Federal Food and Drug Administration
recommends patients with one of the recalled defilbrillators should
consult with their physician immediately.
