FDA classifies Boston Scientific’s recall of Obsidio Embolic as most serious
Boston Scientific has issued a recall about its premixed embolic agent, Obsidio Conformable Embolic (Obsidio Embolic), which is intended to obstruct blood flow to particular blood vessels. This recall has been classified as Class 1, the most serious category, by the FDA. The purpose of the embolic agent is to obstruct hypervascular tumours and halt bleeding peripheral blood arteries. The necessity for significant procedures, such as bowel resection or colostomy diversion, is associated with the worst negative health outcomes. The FDA issues a warning that the aliquot approach may produce non-target embolisation, which may result in longer hospital stays, more surgical procedures, or even fatalities. It may also obstruct blood and oxygen flow to organs, including the small bowel. When administering Obsidio Embolic during lower gastrointestinal haemorrhage embolisation procedures, the manufacturer has not recommended using the aliquot approach. There have been 11 accidents as a result of the recall, including seven injuries and two fatalities. Since February 2024, Boston Scientific has conducted 1,594 device recalls.
