Guidant Defibrillators Recalled Due to Risks

By: Peter Kent Posted on: 2008-08-25 Downloads: 19 ** Print Article ** ** Copy Article ** Please Rate this Article 5 out of 54 out of 53 out of 52 out of 51 out of 5  Not yet Rated

Article Summary: The guidant defibrillators are medical devices used to restore a heart to normal heartbeats. However, some of the defibrillators have been failing patients, leading to sever complications that may lead to death.

When an individual suffers from heart fibrillation they often undergo a surgical procedure where an implanted cardio-defibrillator (ICD) is given to the patient. The ICD defibrillators act as a "heart normalizer" and restore the heart back to its normal rhythm. The defibrillators are considered a technological advancement in the medical community and have helped save lives for patients suffering from life-threatening arrhythmia in 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.

The company admittedly sold the ICDs even though the company knew they were defective and may cause serious ailments as well as death among patients.

In the article, the defective defibrillators being produced in 2002 may have been defective and the company was allegedly aware of this. 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.

The Department of Justice (DOJ) has issued subpoenas to Guidant regarding the defective defibrillators. 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.

Article Source: http://www.upublish.info

About the Author:
Peter Kent
For more on the defective defibrillators, visit http://guidant.legalview.com/. Additionally, use the LegalView homepage at http://www.LegalView.com and peruse other issues of interest such as the Digitek digoxin recall or the Chantix risks.