Defibrillators May Cause Damage to Patients
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.
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.
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. The company then issued an additional safety warning that some of the company's models were unsafe and may 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. Accordingly, the FDA has issued Guidant several Class II recalls for these products:
* 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 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. It is advisable for individuals who received the faulty defibrillators to locate legal consultation.
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