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April 23, 2024

FDA issues most serious recall against Boston Scientific’s blood vessel blocking device

A building with blue tinted windows sits behind a patio with chairs and umbrellas. Photo | Courtesy Boston Scientific Boston Scientific headquarters, Marlborough

The U.S. Food and Drug Administration has issued a recall of Boston Scientific’s Obsidio conformable embolic medical device after an investigation found using the product for lower gastrointestinal bleeding embolization can result in a high risk of bowel ischemia, otherwise known as reduced or restricted blood flow.  

The Marlborough-based company’s Obsidio conformable embolic formula is a premixed embolic agent used to block blood flow to targeted blood vessels by forming a solid cast around the vessel. The device is used to specifically embolize tumors and restrict blood flow to surrounding bleeding blood vessels, according to the FDA’s notice of recall, which is current as of April 17. 

The FDA investigation found administering the product in certain ways can block blood flow to organs outside the intended destination, which may lead to major surgery, extended hospitalization, or death. The FDA reported 11 incidents, seven injuries, and two deaths.   

The FDA recall has been issued as a correction and categorized as a Class I recall, the administration's most serious and dangerous classification. Per the FDA’s website, a correction signifies a product does not need to be physically removed from its location of use, but it must undergo a repair, modification, adjustment, relabeling, destruction, or inspection.

A total of 1,594 devices were recalled in the U.S. by Boston Scientific, initiated on February 20, with distribution dates between May 8 and Feb. 8. On Feb. 21, the company issued an urgent medical device product advisory to customers stating that Boston Scientific does not recommend the use of the aliquot technique for lower GI bleed embolization procedures with the device.

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