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April 17, 2024
FDA Issues Recall Notice for Boston Scientific’s Obsidio Conformable Embolic
April 17, 2024—The FDA announced that Boston Scientific recalled its Obsidio conformable embolic for increased bowel ischemia risk when used for lower gastrointestinal (GI) bleeding. The FDA advised that this recall is a correction, not a product removal. The agency has identified this as a class I recall.
According to the FDA, Boston Scientific initiated the recall on February 20, 2024. The company issued an Urgent Medical Device Product Advisory to customers explaining that use of the aliquot technique is not recommended for lower GI bleed embolization procedures with Obsidio embolic because of the increased risk to the patient. The FDA recall announcement is available online here.
The FDA stated that the recall applies to Obsidio conformable embolic distributed from May 8, 2023, to February 8, 2024, and there were 1,594 devices recalled in the United States. The product codes are available on the FDA Medical Device Recall Database here.
As outlined in the FDA recall, the Obsidio conformable embolic is a premixed embolic agent delivered minimally invasively to 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 occlude blood flow in peripheral blood vessels that are bleeding and/or hemorrhaging.
Boston Scientific is recalling Obsidio embolic by issuing a correction. An investigation determined that delivery of Obsidio embolic using the aliquot technique for lower GI bleeding embolization poses a high risk of bowel ischemia. The most serious and most common adverse health consequence is the need to perform major surgery such as bowel resection and/or diverting colostomy. There were 11 incidents reported, seven injuries, and two deaths related to this issue, advised the FDA.
Boston Scientific does not recommend that the aliquot technique be used to deliver Obsidio embolic for lower GI bleed embolization procedures, stated the FDA recall notification.
On April 17, Boston Scientific provided the following statement to Endovascular Today:
Boston Scientific issued a product advisory in February 2024 recommending that physicians not use the aliquot technique when performing embolization for lower GI bleeding with the Obsidio conformable embolic as dilution of the material may occur, which can alter the performance of the device. This advisory was recently classified by the FDA per its standard recall classification process.
This recommendation for physicians has not changed since the time of the February advisory and there is no action required by patients who have already had procedures performed with the technology. 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.
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