Boston Scientific Class I Recall Linked to Two Deaths

Boston Scientific’s Obsidio Conformable Embolic recall was recently hit with FDA’s Class I classification. The recall is categorized as a correction, not a product removal and comes after the company determined increased risk of bowel ischemia when using a specific delivery method with the agent.

The Obsidio Embolic is a premixed embolic agent delivered minimally invasively to block blood flow to specific blood vessels. After injected, the agent creates a solid cast in the vessel and stops blood flow to treat hypervascular tumors and to occlude blood flow in peripheral blood vessels that are bleeding or hemorrhaging.

Boston Scientific’s correction focuses on a delivery method used for Obsidio Embolic, namely the aliquot technique. The company said it is issuing the recall after determining that using the aliquot technique, which is commonly used in embolization procedures, to deliver the agent for lower gastrointestinal bleeding embolization had a high risk of bowel ischemia.

"When the aliquot technique is used, a small amount of the Obsidio Embolic is injected into a catheter, followed by a saline and/or contrast flush," a spokesperson from Boston Scientific told MD+DI. "This is a technique that is performed by physicians in many clinical scenarios using a variety of embolics as it allows for continued use of the delivery catheter."

The most common serious adverse events when complications occur include the need to perform major surgery like bowel resection and diverting colostomy. The company issued an Urgent Medical Device Product Advisory to its customers on Feb. 21, explaining that it does not recommend that the aliquot technique be used to deliver Obsidio Embolic for lower GI bleed embolization procedure and warned that doing so may prevent blood and oxygen flow to organs including the small bowel, or non-target embolization, which could lead to prolonged hospitalization, additional surgery need, or death.

“Boston Scientific issued a product advisory in February 2024 recommending that physicians not use the aliquot technique when performing embolization for lower gastrointestinal bleeding with the Obsidio Conformable Embolic as dilution of the material may occur, which can alter the performance of the device,” a spokesperson said. “This advisory was recently classified by the FDA per its standard recall classification process.

Currently, 11 incidents have been reported, seven injuries, and two deaths related to the recall.

“… There is no action required by patients who have already had procedures performed with the technology,” according to the spokesperson. “The Obsidio Embolic remains safe for use as labeled and continues to be available for embolization of blood vessels in the peripheral vasculature to control internal bleeding and hemorrhaging.”