Guidant Defibrillators Recalled Due to Risks

There are many medical devices used in the health industry to help save lives or to improve the quality of life of millions of individuals. In general, defibrillators are an electrical device used to counteract fibrillation of the heart muscle and restore normal heartbeat by applying a brief electric shock. Implanted cardio-defibrillators (ICDs) are used to shock the heart into normal rhythm after a patient suffers ventricular tachycardia or fibrillation, which are rapid, life-threatening arrhythmias originating in the lower chambers of the heart.

Guidant Failed to Disclose Known Flaws in its Defibrillators for Three Years

Guidant came under fire in the spring of 2005 after The New York Times reported that it failed to alert physicians and heart patients about a potential problem with the VENTAK PRIZM DR model defibrillator.

Since then, Guidant has admitted to knowing of malfunctions in its ICDs for three years but has continued to sell the defective ICDs, allowing them to be surgically implanted in patients, knowing that these patients were at risk for device failures that could lead to severe complications including death.

The New York Times reported that Guidant knew of the defects in a small number of its defibrillators as early as 2002 and yet continued to sell the old models, even though it had corrected the defect and was manufacturing newer models. In addition Guidant did not inform doctors and patients of the defect until it knew that the New York Times article would be published.

The FDA Recalls 50,000 Guidant ICDs

The Food and Drug Administration (FDA) oversees the safety of medical devices and on June 17, 2005, issued a nationwide recall of nearly 50,000 Guidant ICDs. These devices may develop an "internal short circuit without warning," resulting in failure to deliver a shock when needed and are subject to memory errors. Less than a week later, Guidant issued a second safety advisory informing doctors to stop using five of its ICD models because a defective switch could cause them to malfunction.

Presently, Guidant is responding to Department of Justice administrative subpoenas requesting information related to faulty manufacturing, as well as FDA observations regarding manufacturing and quality control processes. New York Attorney General Eliot Spitzer filed suit against Guidant on November 3, 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 Subject to FDA Recall

As part of the FDA's oversight of medical devices the Administration has classified three classes of recalls, Class I, II, and III. Class I recalls are the most serious type of recall and indicates that there is a reasonable chance that the product will cause serious health problems or death. The FDA issued a Class I recall of the following Guidant devices:

* CONTAK RENEWAL (Model H135)

* CONTAK RENEWAL 2 (Model H155)

* CONTAK RENEWAL 3 AVT (Models M150, M155)

* CONTAK RENEWAL 3 AVT HE (Models M157, M159)

* 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)

In a Class II FDA, recall there is a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems. The FDA also issued the following Class II recall of the following Guidant devices:

* CONTAK RENEWAL 3 (Model H170, H173, H175)

* CONTAK RENEWAL 3 DS HE (Model H177)

* CONTAK RENEWAL 3 HE (Model H177, H179)

* CONTAK RENEWAL 4 (Model H190, H195)

* CONTAK RENEWAL 4 HE (Models H197, H199)

* PRIZM 2 DR (Model 1861)

* RENEWAL RF (Model H230, H235)

* RENEWAL RF HE (Model H239)

These recalls have been issued because the products pose very serious health risks or death for patients. The FDA is continuing to investigate other defibrillators on the market. Patients who have experienced health problems or injury related to these devices should seek legal help.

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