FDA Recalls Guidant Defibrillators

There are several medical products or devices used in the health industry to improve the quality of life or to save the lives of millions of people. Generally, defibrillators are an electrical device used by doctors to counteract fibrillation of the muscles of the heart and restore normal or regular heart beat by applying an electric shock. Health care professionals use Implanted Cardio-Defibrillators (ICDs) to shock the heart into normal heart rate or rhythm after a patient suffers from fibrillation and/ or ventricular tachycardia, which are fast and life threatening arrhythmias occurring ion the chest’s lower chamber.

Guidant Failed to Notify Defects in Defibrillators for Three Years

Guidant came under fire in 2005 after the report published in The New York Times revealed that the company failed to warn the heart patients and doctors about the potential associated with the VENTAK PRIZM DR model defibrillator. Thereafter, Guidant admitted that it knew about the defects in its ICDs for pats three years but it continued to sell them, thus, allowing them to be implanted in the patients, knowing that these patients were at an increased risk of device failure that could even lead to several severe health complications including death.

According to the report published in The New York Times, Guidant knew of the faults as early as 2003 but it continued to sell the old models of defibrillators, even though it corrected the faults and manufactured new models. Additionally, Guidant failed to inform the patients and doctors about this defect until the article published in the New York Times.

The FDA Withdraws 50,000 Guidant ICDs

The United States federal Food and Drug Administration (FDA) looks after the safety of medical products and devices. On June 17, 2005, FDA announced a nationwide recall of 50,000 ICDs manufactured by Guidant. There is high possibility that these devices may lead to “internal short circuit without warning,” which may result into failure to deliver a shock when required and may lead to memory errors. Less than after a week, Guidant issued another safety advisory informing health care professionals to stop using six of its ICD models due to defective switch that could lead to malfunction.

Currently, Guidant is reacting to the Department of Justice administrative subpoenas asking for the information related with the defective manufacturing and FDAs observations regarding the quality control processes and manufacturing. New York Attorney General Eliot Spitzer filed a lawsuit against Guidant in November 2005, stating, “We wouldn’t permit this type of conduct in connection with the sale of cars or washing machines. It is simply unconscionable that it occurred with a critical medical device.”

Devices Recalled by FDA

Because of the FDAs oversight of medical products or devices, the agency has classified three recall classes, Class I, Class II and Class III. Class I recalls are the most serious recall indicating that there is possibility that the product may cause serious health problems including death. The FDA announced Class I recall on the following Guidant medical devices:

• CONTAK RENEWAL (Model H135)
• CONTAK RENEWAL 2 (Model H155)
• CONTAK RENEWAL 3 AVT HE (Models M157, M159)
• CONTAK RENEWAL 3 AVT (Models M150, M155)
• CONTAK RENEWAL 4 AVT (Model M170, M175)
• CONTAK RENEWAL 4 AVT HE (Models M177, M179)
• VENTAK PRIZM 2 DR (Model 1861)
• VENTAK PRIZM AVT (Model 1900)
• VITALITY AVT (Model A135, A155)

According to the FDA, in the Class II recall, there are chances that the medical device may cause reversible or temporary health problems and there are remote chances that the device may cause severe health problems. The FDA announced Class I recall on the following Guidant medical devices:

• CONTAK RENEWAL 3 HE (Model H177, H179)
• CONTAK RENEWAL 3 DS HE (Model H177)
• CONTAK RENEWAL 3 (Model H170, H173, H175)
• CONTAK RENEWAL 4 HE (Models H197, H199)
• CONTAK RENEWAL 4 (Model H190, H195)
• PRIZM 2 DR (Model 1861)
• RENEWAL RF HE (Model H239)
• RENEWAL RF (Model H230, H235)

The Food and Drug Administration announced the recall of these products because they possess a serious health risks including death for the patients. The FDA continued to investigate other defibrillators available in the market. Patients who have experienced serious injuries and health problems should seek the help of an experienced medical device attorney.