Boston Scientific Recalls Carotid Wallstent Monorail Endoprosthesis

August 26, 2025—The FDA advised that Boston Scientific has recalled the carotid Wallstent monorail endoprosthesis.

The advisory stated that the recall was conducted because a manufacturing defect created an inner lumen smaller than specifications, causing resistance when withdrawing the stent delivery system. The affected stent systems could cause serious harm, such as injury to the blood vessel, damage to the stent, or release of debris that could travel to the brain and cause a stroke.

According to the FDA, this action has been identified as the most serious type of recall, involving removing the devices from where they are used or sold because the device may cause serious injury or death if they continued to be used.

As of July 29, 2025, Boston Scientific has reported six cases that required additional intervention to recover the device. Boston Scientific has not reported any deaths associated with this issue, noted the FDA.

The FDA advised that on July 7, 2025, Boston Scientific sent all affected customers an Urgent Medical Device Removal Letter.

As outlined by the FDA, the letter recommended the following actions:

• Immediately stop using affected devices.
• Remove affected devices from inventory, clearly segregate, and return to Boston Scientific.
• Complete and return the Reply Verification Tracking Form, even if no affected devices remain.
• Share this information with all staff, facilities, and customers who may have received the product.

The FDA stated that health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch.

More information is available on the FDA website here.