FDA Recall of Boston Scientific’s Artery Stents

FDA officials and manufacturer Boston Scientific are recalling three types of Boston Scientific’s carotid artery stents and delivery systems

    NexStent Monorail,
    NexStent Carotid Stent, and
    Monorail Delivery System

for unnecessary and potentially lethal dangers posed to heart surgery patients. This recall applies to all stent and delivery system products distributed to hospitals from June 19, 2007, through May 5, 2008 (approximately 2,700 defective medical devices) .

A coronary stent is a slender device placed in a coronary artery to treat coronary heart disease; specifically, these stents prop open arteries. Coronary stents are used in a procedure called percutaneous coronary intervention (PCI), more commonly known as oronary angioplasty or just plain old angioplasty. NexStent is specifically used for clogged arteries in the neck that carry blood from the heart to the brain.

The problem with Boston Scientific’s defective (and now thankfully FDA recalled) defective carotid artery stents was that the tip had a great likelihood of coming off during angioplasty, which can cause a punctured artery, stroke, even more invasive emergency surgery to retrieve the stent tip, and other dangers.

FDA officials have stated there is no danger of broken stent tips for those who already have a stent in place; this defective medical device danger exists during the initial application of Boston Scientific carotid artery stents. The tip of the stent deliver system for these three recalled products detaches while it is run through the midsection up to the patient’s neck.

Patients with upcoming heart surgeries involving a carotid artery stent procedure should consult with their heart surgeon to make sure that none of these recalled, defective Boston Scientific stents will be used.

I encourage any Tennessee resident injured by any of these defective medical devices to give HHP’s Nashville law offices a call or complete our dangerous medical device injury response form. There are time limits to successful defective device lawsuits and settlements in Tennessee; the more quickly you act, the greater your chance for fair compensation for your medical injury caused by Boston Scientific’s defective and dangerous artery stents.

Author Bio

Jim Higgins, founder of the Higgins Firm, is a seasoned personal injury attorney with deep roots in Nashville, Tennessee. A 4th generation Nashvillian, Jim carries on the legal legacy of his father, a judge for over 30 years. After graduating from the University of Memphis School of Law, Jim’s career began on the other side of the courtroom, defending insurance companies and learning their tactics for minimizing settlements. However, he soon realized his true calling was fighting for the rights of the injured, and for the past several years, he has exclusively represented plaintiffs in personal injury cases.

Since then, his dedication and skill have earned him membership in the prestigious Million Dollar Advocates Forum, an organization limited to attorneys who have secured million and multi-million dollar verdicts and settlements for their clients. Licensed to practice in Tennessee, Kentucky, and Georgia, Jim focuses on personal injury, product liability, medical malpractice, and workers’ compensation cases. His exceptional work has been recognized by his peers, earning him a spot on the Super Lawyers list from 2021 to 2024, a distinction awarded to only a select group of accomplished attorneys in each state.

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