Obsidio Conformable Embolic Recall Issued After Reports of Deaths, Serious Injuries

Federal officials indicate that a blood product sold by Boston Scientific for prevention of embolism, known as the Obsidio Conformable Embolic, has been linked to several reports of injuries and at least two reports of deaths, due to problems with the product preventing oxygen and blood flow to organs.

On April 17, the U.S. Food and Drug Administration (FDA) announced a Boston Scientific Obsidio Conformable Embolic recall, after the agency categorized a product correction originally issued by the manufacturer in February 2024 as a Class I medical device recall, suggesting that continued use of the product could cause severe injury or death.

Obsidio Conformable Embolic is an injected, ready-to-use, minimally invasively product designed to block blood flow in particular blood vessels. Once injected, it solidifies in the vessel, stopping blood flow in tumors with excessive blood supply and bleeding in peripheral blood vessels.

However, Boston Scientific has received at least 11 reports of serious problems with Obsidio Conformable Embolic, including seven incidents that resulted in severe injuries and two deaths.

Following an investigation into the problems, Boston Scientific found that administering Obsidio Embolic for lower gastrointestinal bleeding embolization using the aliquot technique, a common method in embolization procedures, significantly increases the risk of restricting blood flow to the bowels. This can lead to tissue damage and severe complications, like bowel perforation and sepsis.

The investigation also found that using Obsidio with the aliquot technique may block blood and oxygen flow to organs, causing ischemia or unintended embolization, leading to prolonged hospitalization, additional surgery, or death.

Boston Scientific issued an Urgent Medical Device Product Advisory to customers on February 21, warning healthcare providers to immediately stop using the aliquot technique. The FDA has now determined this constitutes a class I recall, which is the strongest recall designation the agency can assign. The recall affects Obsidio Conformable Embolic distributed between May 8, 2023 and February 8, 2024.

Customers with questions can contact their Boston Scientific representative. The FDA urges health care providers and consumers who experience adverse events or reactions during the use of this product to submit a report to the MedWatch adverse event reporting program.