The recall comes after Boston Scientific reported issues with deployment and expansion of the stents.
The U.S. Food and Drug Administration has leveled its most level of recall against a stent from Marlborough medical device manufacturer Boston Scientific, after the stent was linked to more than 160 serious injuries and three deaths.
“Boston Scientific is actively investigating and addressing the situation. We understand the importance of product availability and are working to minimize disruption for physicians and patients,” Jessica Sachariason, director and business partner global corporate communications endoscopy at Boston Scientific, wrote in an email to WBJ.
The FDA issued a Class I recall for six models of Boston Scientific’s AXIOS stents, which are used to drain fluid-filled sacs forming near the pancreas, often after pancreatitis.
The recall comes after Boston Scientific reported issues with deployment and expansion of the stents, used in the manufacturer’s overall AXIOS Stent and Electrocautery Enhanced Delivery System, according to the recall posted on Wednesday by the FDA. Boston Scientific reported 167 serious injuries and three deaths associated with the stent issues.
Boston Scientific is initiating a removal of certain stent lots, said Sachariason.
“There is potential that the delivery sheath may not retract enough to allow deployment, and/or the stent may not fully expand even when the sheath is retracted,” Sachariason wrote.
Additionally, Boston Scientific sent a letter to AXIOS stent customers on Dec. 19 with a number of advisory measures, including to stop further distribution or use of the affected stents, post the recall information for handlers and users to see, and to share the notice with healthcare professionals within their organizations, according to the recall.
Boston Scientific’s most recent Class I recall comes after the manufacturer was handed another in April 2024 for its Obsidio conformable embolic medical device after an FDA investigation found the device
could block blood flow to organs outside the intended target.
In December 2024, Boston Scientific
recalled a subset of its Accolade pacemakers whose malfunctions had been linked to two patient deaths.
With 2,800 local employees, Boston Scientific is Central Massachusetts’ second-largest manufacturer, according to data collected by WBJ’s Research Department. In 2024, the public company generated $16.7 billion in revenue.
Boston Scientific’s stock was trading at $76.22 per share when the markets closed on Monday, down 0.8% following the day of trading.
Mica Kanner-Mascolo is a staff writer at Worcester Business Journal, who primarily covers the healthcare, manufacturing, and higher education industries.
