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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.

Full post as published by Tennessee Law Blog on August 15, 2008 (boomark / email).