Boston Scientific said yesterday that it has recalled its NexStent products because of a defective stent delivery system. The Food & Drug Administration (FDA) has deemed the NexStent recall a Class I recall. Such recalls are for dangerous or defective products that predictably could cause serious health problems or death.
NexStent products are used in patients to treat a blockage (stenosis) in the carotid artery, known as carotid artery disease. The two carotid arteries (located on either side of the neck) supply blood to the brain. The device is used in a procedure called carotid artery stenting (CAS), in which the physician places the self-expanding stent in the carotid artery to keep the artery open and to help prevent future narrowing of the artery.
The stent uses one of two delivery systems called the Monorail and Over the Wire, according to the FDA. The recall applies to the Monorail system as well as the stent itself.
The NexStent recall was initiated because the tip of the device used to implant the stent can break off and may damage the blood vessel wall or lead to stroke. If the device malfunctions, emergency surgery could be required to remove the tip. The recall includes NexStent products made from June 2007 to May 2008.
Nearly 2700 NexStent products are involved in this recall. The recall does not affect stents that have already been implanted. That is because the problem caused by the defect only occurs during implantation.
Boston Scientific first made its customers aware of the NexStent products recall via a letter dated June 6, 2008. The FDA said that healthcare professionals and consumers may report any problems with the NexStent system to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Patients with questions about recalled NexStent products should contact their doctors.
“All U.S. hospitals have responded to Boston Scientific, and a significant number of the distributed devices have been returned,” Boston Scientific said in a statement.
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