The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall.
The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system to block or occlude blood flow to specific blood vessels.
Boston Scientific issued a correction for the Obsidio embolic after an investigation, according to the FDA. The investigation found a high risk of bowel ischemia — the cutting off of blood from and oxygen to the small bowel — when doctors delivered the embolic using the aliquot technique to treat gastrointestinal bleeding embolization.
The FDA said there are reports of 11 incidents related to the problem, including seven injuries and two deaths. The recall involves 1,594 devices distributed between May 8, 2023 and Feb. 8, 2024.
According to the FDA, Boston Scientific sent out a notice to health providers on Feb. 21. The notice explained that the use of the aliquot technique is not recommended for lower GI bleed embolization procedures with Obsidio embolic, due to increased patient risk.
The FDA has more information about the Obsidio embolic recall on its website.
Boston Scientific acquired Obsidio and its blood vessel embolization material technology in 2022.