Boston Scientific Has a Class I Embolization Tech Recall

The U.S. Food and Drug Administration has identified Boston Scientific’s recall of its Obsidio Conformable Embolic as Class I.
 
Boston Scientific recalled the device by issuing a correction—an investigation showed delivery of Obsidio Embolic using the commonly used aliquot delivery technique for embolizations, for lower gastrointestinal (GI) bleeding embolization has a high risk of bowel ischemia.
 
The most serious and most common consequence of this is major surgery like bowel resection and/or diverting colostomy. Using this product with the aliquot technique might prevent blood and oxygen flow to organs including the small bowel or non-target embolization.
 
This can lead to prolonged hospitalization, the need for additional surgery, or death. Boston Scientific advised against using the aliquot technique to deliver Obsidio Embolic for lower GI bleed embolization procedures.
 
11 incidents were reported, with seven injuries and two deaths related to the issue.
 
Boston Scientific issued an Urgent Medical Device Product Advisory to customers on February 21. The notice explained using the aliquot technique is not recommended and to post the notice near the product to ensure the information is easily accessible.
 
Obsidio Embolic is a premixed embolic agent that’s delivered minimally invasively to occlude blood flow to specific blood vessels. After it’s injected, Obsidio Embolic creates a solid cast in the vessel and stops blood flow. It’s meant for a single use to embolize hypervascular tumors and block blood flow in peripheral blood vessels that are bleeding and/or hemorrhaging.
 
Boston Scientific acquired Obsidio in 2022.