In a letter dated July 9, 2026, Boston Scientific told customers to identify affected EnRoute transcarotid neuroprotection system (NPS) and EnRoute NPS Plus products and cease use and distribution. Customers should return affected products to the Marlborough, Massachusetts-based company.
The EnRoute transcarotid system transports emboli away from the carotid artery circulation. It reverses blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. The company added EnRoute to its portfolio through its $1.18 billion acquisition of Silk Road Medical in 2024.
Boston Scientific said the removal of certain EnRoute NPS and NPS Plus lots comes after reports of arterial sheath tip separation or partial tip separation during use.
Separation of this nature may require endovascular or surgical retrieval of the retained tip. Complications may include embolism, stroke, transient ischemic attack, restenosis or thrombosis.
As of July 9, Boston Scientific reports one serious injury and no deaths associated with the issue.
The company told affected customers to immediately stop further use or distribution and segregate affected product. They should return the product to Boston Scientific and notify relevant personnel in their facility who use these devices.
