August 22, 2025
Washington, D.C. — The U.S. Food and Drug Administration (FDA) has issued a Class I recall—the most serious type—for Boston Scientific’s Carotid WALLSTENT Monorail Endoprosthesis due to a manufacturing defect that may pose significant safety risks during carotid artery stenting procedures.
According to the FDA, the defect involves a narrower-than-intended lumen in the delivery system, which can cause resistance when withdrawing the device after deployment. This resistance may result in serious complications, including vessel trauma, stent damage, or cerebral embolization.
Boston Scientific initially alerted healthcare providers on July 7, 2025, through an Urgent Medical Device Removal Letter. As of July 29, the company has documented six cases where clinicians experienced this issue, although no patient deaths or permanent injuries have been reported. The company has stated that these incidents required additional procedural maneuvers but were successfully resolved without long-term adverse effects.
The recall impacts more than 26,000 units globally, with approximately 1,333 distributed within the United States. Affected customers are instructed to immediately discontinue use of the product, segregate existing inventory, and return the affected units using a reply verification tracking form. Boston Scientific has committed to processing returns and issuing credits promptly.
The Carotid WALLSTENT Monorail is a self-expanding stent system commonly used in patients with atherosclerotic carotid artery disease who are at elevated risk for stroke. It is particularly valuable for patients who may not be ideal candidates for open surgery. Because the device is deployed in a critical vascular territory, any technical issues during the deployment or retrieval process can have significant consequences.
"Resistance during stent withdrawal isn’t just a technical inconvenience, it’s a red flag for potential cerebral complications," said Dr. Jacqueline Harris, Director of Vascular Surgery at a major academic medical center. "Swift action is required to protect procedural integrity and patient safety."
Hospitals, surgical centers, and outpatient interventional radiology units must work closely with their supply chain and quality assurance departments to ensure strict compliance with the recall. Immediate priorities include inventory audits, submission of verification forms, coordination of product returns, and communication to interventional and surgical teams.
Experts emphasize that this recall also calls attention to the importance of having redundant device options available. Hospitals that rely heavily on a single vendor’s device lines may face disruption to scheduling, especially for high-acuity cases such as symptomatic carotid stenosis.
"Institutions must rapidly validate unaffected inventory and identify substitute devices to avoid case delays or cancellations," noted Dr. Harris. "This situation underlines the need for agile procurement strategies and vendor diversification."
Regulatory agencies are monitoring the situation closely. The FDA noted in its recall notice that no long-term health consequences have yet been associated with the product, but the potential for embolic stroke or vascular damage makes it imperative that providers remove all affected inventory.
The recall is not expected to impact Boston Scientific’s broader product line, though it raises quality assurance questions at a time when the medical device industry is under increased scrutiny from regulators and hospital networks alike. According to MedTech Dive, Boston Scientific has reiterated its commitment to safety and is cooperating fully with FDA investigations and field communications.
In light of this event, hospitals are being encouraged to review their recall response protocols, particularly around how recall notices are disseminated internally and how promptly affected products are removed from stock. A failure to respond quickly could increase liability and compromise patient safety.