FDA Classifies Boston Scientific's Recall For Device To Stop Blood Flow As 'Most Serious'

On Wednesday, Boston Scientific Corporation BSX said it recalled Obsidio Embolic by issuing a correction. The FDA has identified this as a Class I recall, the most severe type of recall.

An investigation determined that delivery of Obsidio Embolic using the aliquot technique, a commonly used delivery method in embolization procedures, for lower gastrointestinal (GI) bleeding embolization, implies 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 (ischemia) or non-target embolization, all of which may lead to prolonged hospitalization, the need for additional surgery, or death.

Eleven incidents were reported, seven injuries, and two deaths related to this issue.

The FDA said that recall is a correction, not a product removal.

On February 21, Boston Scientific issued an advisory notice explaining that the aliquot technique is not recommended with Obsidio Embolic when used for procedures treating lower GI bleeding.

The Obsidio Conformable Embolic (Obsidio Embolic) is a premixed embolic agent delivered minimally invasively to block (occlude) blood flow to specific blood vessels. 

After injection, Obsidio Embolic creates a solid cast in the vessel and halts blood flow. It is intended for single use to embolize hypervascular tumors and to occlude blood flow in peripheral blood vessels that are bleeding and/or hemorrhaging.

The company has issued a recall for around 1,600 devices distributed between May 8, 2023, and February 8, 2024.

In January, Boston Scientific agreed to acquire Axonics Inc AXNX for $71 in cash per share, representing an enterprise value of approximately $3.4 billion and an equity value of roughly $3.7 billion.

The Axonics product portfolio includes the Axonics R20 and the Axonics F15 Systems used to deliver sacral neuromodulation therapy, a minimally invasive procedure for overactive bladder and fecal incontinence. 

Price Action: BSX shares are down 0.32% at $67.71 on the last check Thursday.