FDA Slaps Embolization Device With Class I Recall After Deaths

The Obsidio Conformable Embolic recall related to an increased risk for bowel ischemia is the most serious kind, the FDA said on Wednesday, citing two deaths associated with the issue.

An investigation by maker Boston Scientific determined that a high risk of bowel ischemia was associated with delivery of the premixed embolic agent via the aliquot technique -- a common delivery method for embolization procedures -- for lower gastrointestinal (GI) bleeds.

A total of 1,594 devices in the U.S. are included in the recall, which is a corrective action rather than a product removal.

"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," said FDA in its announcement of the class I recall. "Use of this product with the aliquot technique may prevent blood and oxygen flow to organs including the small bowel (ischemia) or non-target embolization, all of which may lead to prolonged hospitalization, the need for additional surgery, or death."

To address the issue, Boston Scientific sent an urgent advisory to its customers, warning that "the aliquot technique is not recommended for lower GI bleed embolization procedures with Obsidio Embolic due to the increased risk to the patient" and calling for this information to be immediately posted near the product.

To date, 11 incidents have been reported in relation to the bowel ischemia issue, including seven injuries and two deaths.

Obsidio Embolic is an FDA cleared, single-use product indicated for the minimally invasive embolization of hypervascular tumors and to occlude blood flow in bleeding or hemorrhaging peripheral blood vessels. After injection, the premixed embolic agent "creates a solid cast in the vessel and halts blood flow," the FDA explained.

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