Boston Scientific Flextome
The Boston Scientific corporation recalled 40,000 of its Flextome products, devices that were implanted in patients as a treatment for blocked coronary arteries. The recall came after the company received eight complaints regarding the detachment of the device's end during its insertion into a patient. This defect resulted in three cases of additional surgery. The recall applied to all of the Boston Scientific Flextome cutting angioplasty balloon devices that were approved by the Food and Drug Administration (FDA) in September of 2005, just three months before its recall. The Flextome is the second device of Boston Scientific that uses a balloon catheter that was recalled.
The Flextome is inserted through the skin and threaded up in the arteries around the heart.
Additionally, it is different from the regular angioplasty balloons, because it has microsurgical blades on the outside of it. The blades cut through the fatty deposits in the arteries, so that a lot of pressure isn't needed. During the angioplasty procedure, the balloon catheter is inserted into the congested artery. This balloon is then inflated to open up the blood vessel, thereby forcing aside the plaque that accumulated within the artery.
However, after the surgical procedure is done, and the catheter is removed, the shaft on the Flextome can separate. This specific problem was reported eight times, and three of them required additional surgery. Thus, resulting in more risky procedures, on top of the angioplasty. Fortunately, there are no known cases of problems occurring after a safe catheter removal, so if you had a successful surgery, you are most likely in the clear. The FDA states that the recall only affects those who had complications during the surgery. However, if you were victim to a faulty stent, due to product malfunction, you may be entitled to compensation.
In December 2005 a Class I, the most dangerous, recall of the Boston Scientific Flextome Cutting Balloon System occurred. Just a few months after it's FDA approval, the risks presented too much danger to continue its use. Those who had the surgery are at a risk of ruptured arteries, or having the catheter block the artery. Medical procedures are supposed to bring health to the sick, and not continue to add to the list of risks.
You may be among those who were seriously injured because of the defect found in the Flextome device. There is no reason to hesitate in having your case evaluated, because you are entitled to compensation for the injuries, and complications that you have sustained. Contact a lawyer who is experienced in handling defective medical device cases to answer all of your questions about Flextome. An experienced defective medical device lawyer is usually armed with all the pertinent information that you might need regarding the defective device. This knowledge will help your lawyer ascertain if you have enough grounds to file a personal injury claim. A lawyer will make sure that you get the maximum compensation that you deserve.
Be mindful of the fact that there are time limitations that restrict the filing of personal injury cases. This makes it imperative that you to contact a lawyer as soon as you feel ready. Personal injury claims can usually only be filed within two years of the injuries. Failure to file a claim within this given period of time will result in failure to get the compensation that you deserve for your injuries. Take note that financial compensation will not only cover the medical expenses that you incurred, but also the pain and suffering that you endured, and your loss of income.
