Boston Scientific Voluntarily Withdraws Heart Stent

On August 14, 2008, the United States Food and Drug Administration announced that Boston Scientific has withdrawn Monorail Delivery Systems and NexStent Carotid Stents distributed from June 2007 to May 2008 in a Class I recall. A Class I recall indicates a defective or dangerous product responsible for causing serious health problem or even death. Patients using Nextent were informed about the defective device in June 2008 but the FDA announced this recall publicly in late 2008. A large or unknown no. of patients might have undergone stenting procedure with NexStent Carotid Stent during that period.

Defining Carotid Stent

The NexStent Carotid Stent is a popular medical device used for treating blockage that occurred because of carotid artery disease. It is used in a surgery called Carotid Artery Stenting (CAS). Surgeons place stent in the carotid artery in order to keep the artery open. In this surgery, doctors place the stent into the neck through a delivery method called the Monorail Delivery System, which is also a part of recall. The United States Food and Drug Administration approves this Drug Eluting Stent (DES) in the year 2006. This recall is linked with every stents distributed by Boston Scientific after June 2007.

The FDA recalled this product due to the increased possibility of the tip of the heart stent delivery system detaching during the procedure of implanting. This may cause blood vessel damage, an emergency surgery to eradicate the detached tip, injury to the artery and strokes.

However, this recall fails to affect the Boston Scientific stents because they were already implanted. This is because the difficulty arises while performing the surgical procedure. If a surgeon implants the stent successfully then the stent’s ability to work effectively is not at all affected.

Legal Advice

If the defective medical stent device has affected you or a loved one then you should immediately seek the advice of an experienced medical device attorney. He will help you in filing a lawsuit against the company so that you may receive some monetary compensation for the medical bills, lost wages, pain and sufferings and other related costs.