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Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal
The FDA is aware that Boston Scientific is recalling he Carotid WALLSTENT Monorail Endoprosthesis due to a manufacturing defect that created an inner lumen smaller than specifications, causing resistance when withdrawing the stent delivery system. Use of 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.
As of July 29, 2025, Boston Scientific has reported six cases that required additional intervention to recover the device. There have been no reported deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at BSCFieldActionCenter@bsci.com or 1-763-415-7700.
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