Boston Scientific updates instructions for recalled embolic agent linked to multiple deaths
Boston Scientific has updated the instructions for a premixed embolic agent that was recalled back in April due to significant safety issues.
Obsidio Conformable Embolic is a premixed embolic agent designed to help embolize hypervascular tumors and occlude blood flow in peripheral blood vessels during interventional radiology procedures. It starts off as an injectable soft solid, flows like a liquid when the user applies force to the syringe and then becomes a soft solid again when necessary.
Multiple customers reported experiencing issues with using the aliquot technique to deliver the embolic agent for lower gastrointestinal (GI) bleeding embolization procedures.
The problems were classified as a Class I recall by the U.S. Food and Drug Administration (FDA), which means using the agent was associated with an increased risk of serious injuries or death. In total, the FDA has linked this issue with 15 patient injuries and four deaths, up considerably compared to the seven injuries and two patient deaths identified at the time of the recall.
Customers must follow updated instructions—no returns necessary
This recall covers more than 1,500 devices distributed to customers from May 2023 to February 2024. Unlike many Class I recalls, however, these products do not need to be removed from the market or returned to the manufacturer. Instead, customers must acknowledge the updated instructions and follow them going forward.
According to the new instructions, customers should not use the aliquot technique or push Obsidio Embolic with saline during GI bleeding embolization procedures. Boston Scientific has also emphasized that no “forceful injections” should be made in or near the Obsidio Embolic.
“Use of this product with the aliquot technique or pushing with saline may cause off-target embolization, ischemia, including of the small bowel, which may lead to prolonged hospitalization, the need for additional surgery such as bowel resection or diverting colostomy, or death,” according to an updated advisory on the FDA website. “Boston Scientific does not recommend altering the Obsidio Embolic by using the aliquot technique or pushing with saline.”
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.