Boston Scientific recalls 1,594 Obsidio Embolic devices in U.S.

Boston Scientific Corporation is recalling 1,594 Obsidio Embolic devices in the U.S. by issuing a correction, according to a post from the FDA. An investigation determined that delivery of Obsidio Embolic using the aliquot technique, a commonly used delivery method in embolization procedures, for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. 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. Use of this product with the aliquot technique may prevent blood and oxygen flow to organs including the small bowel 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 were 11 incidents reported, seven injuries, and two deaths related to this issue.