Boston Scientific Recalls Obsidio Embolic Device

Boston Scientific is recalling (Class 1) its Obsidio Conformable Embolic device to update the use instructions due to a concern about risks when using it anywhere in the gastrointestinal (GI) area. A previous alert noted serious adverse health consequences that were associated with lower GI bleeding, and the company is now updating this based on recent serious adverse events that included all GI bleeding, a recall notice says.

“Use of this product with the aliquot technique or pushing with saline may cause off-target embolization, ischemia (preventing blood and oxygen flow to organs), 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,” the notice says. “Boston Scientific does not recommend altering the Obsidio Embolic by using the aliquot technique or pushing with saline.”

Boston Scientific says there have been 15 injuries and four deaths related to the issue.