Boston Scientific withdraws stent system from market

In a significant development, Boston Scientific has announced a recall of its Carotid Wallstent Monorail Endoprosthesis, a device used during interventional radiological procedures to treat carotid artery stenosis. The recall, which was announced in August 2011, is due to a manufacturing defect that has created an inner lumen smaller than specified.

The U.S. Food and Drug Administration (FDA) has issued a notice for this recall, classifying it as the most serious type, indicating potential for serious injury or death. The FDA has warned that continuing to use the device may cause serious injury or death.

The self-expanding stent, designed to open narrowed carotid arteries, is placed using a catheter over a guidewire or embolic protection device. The defect may cause resistance when the stent delivery system is withdrawn, potentially leading to complications such as injury to the blood vessel, damage to the stent, and the release of debris that could travel to the brain and cause a stroke.

As of July 29, Boston Scientific has confirmed six instances where additional intervention was necessary to recover the affected stent systems. The company has also instructed customers to immediately stop using the Carotid Wallstent Monorail Endoprosthesis, remove them from inventory, and return them to the company.

It is important to note that no fatalities have been reported in relation to the manufacturing defect or the recall as of the latest update. However, the FDA has emphasised the potential harm from using the affected stent systems, and Boston Scientific has sent an Urgent Medical Device Removal letter on July 7 to all affected customers.

This recall affects the Carotid Wallstent Monorail Endoprosthesis specifically, and no broader information about Boston Scientific's other products is provided in this paragraph. The number of reported cases requiring additional intervention to recover the affected stent systems is six, as of July 29.

The Carotid Wallstent Monorail Endoprosthesis should not be used if it has a smaller inner lumen due to the risk of resistance during withdrawal. Boston Scientific urges all customers to follow the instructions provided in the recall notice to ensure patient safety.