The Carotid WALLSTENT Monorail Endoprosthesis is a self-expanding stent used to open narrowed carotid arteries and is placed using a catheter over a guidewire or embolic protection device. The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease and meet the criteria outlined below:
- Patients with neurological symptoms and ≥50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR patients without neurological symptoms and ≥80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, AND
- Patients with a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
The Carotid WALLSTENT Endoprosthesis is contraindicated for use in:
- Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated
- Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
- Patients with uncorrected bleeding disorders
- Lesions in the ostium of the common carotid artery.
Boston Scientific warns:
- Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stent and may cause acute closure of the vessel, requiring additional intervention (carotid endarterectomy, further dilatation, or placement of additional stents).
- The stent may cause a thrombus, distal embolization or may migrate from the site of implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration. In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
- In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent may be required.
- Overstretching of the artery may result in rupture and lifethreatening bleeding.
- Balloon angioplasty of the carotid bifurcation may initiate transient hemodynamic instability consisting of bradycardia or hypotension. Appropriate pharmacologic therapy must be immediately available.
Boston Scientific is recalling the 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.
Using 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. Boston Scientific has not reported any deaths associated with this issue.
On July 7, 2025, Boston Scientific sent all affected customers an Urgent Medical Device Removal Letter recommending 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.
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