The U.S. Food and Drug Administration (FDA) has announced that Boston Scientific is recalling a premixed embolic agent designed to help embolize hypervascular tumors and occlude blood flow in peripheral blood vessels during interventional radiology procedures.
This is a Class I recall, which means using the agent “may cause serious injuries or death.” The recall includes a total of 1,594 devices distributed to customers from May 2023 to February 2024.
Obsidio Conformable Embolic starts off as an injectable soft solid, flows like a liquid when the user applies force to the syringe and then returns to its soft solid state when necessary. According to Boston Scientific, there have been ongoing issues associated with using the aliquot technique to deliver the embolic agent—this method has been linked to a heightened risk of bowel ischemia when used for lower gastrointestinal (GI) bleeding embolization procedures.
“The most serious and the most common adverse health consequence is the need to perform major surgery such as bowel resection and/or diverting colostomy,” according to the advisory. “Use of this product with the aliquot technique may prevent blood and oxygen flow to organs including the small bowel (ischemia) or non-target embolization, all of which may lead to prolonged hospitalization, the need for additional surgery or death. Boston Scientific does not recommend that the aliquot technique be used to deliver Obsidio Embolic for lower GI bleed embolization procedures.”
There have been a total of 11 incidents so far related to this issue, including seven injuries and two patient deaths.
Image courtesy of Boston Scientific.
This recall is a correction, not a product removal
The FDA’s announcement emphasized that this is a correction and not a full product removal. Boston Scientific issued an Urgent Medical Device Product Advisory to customers on Feb. 21 warning customers not to use the aliquot technique for lower GI bleed embolization procedures. Customers were asked to post the notice in a place where it can be seen by anyone who may use the embolic agent.
Boston Scientific’s public comment
“This recommendation for physicians has not changed since the time of the February advisory and there is no action required by patients who have already had procedures performed with the technology,” a Boston Scientific spokesperson told Cardiovascular Business in a statement. “The Obsidio Embolic remains safe for use as labeled and continues to be available for embolization of blood vessels in the peripheral vasculature to control internal bleeding and hemorrhaging.”
Click here to read additional details on the FDA website.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.