FDA alerts to Class I recall of Obsidio Comformable Embolic by Boston Scientific due to risk of serious injuries, death

The FDA is warning consumers of a Class I recall of Boston Scientific’s Obsidio Comformable Embolic because the device has been shown to present a risk for increased bowel ischemia when used for lower GI (gastrointestinal) bleeding, or acute colonic bleeding.

As a pre-mixed embolic agent, the Obsidio Comformable Embolic (Obsidio Embolic) is designed to be injected in a minimally-invasive manner and works to block the flow of blood to specific blood vessels by forming a solid cast in the vessel. Meant for single use, the injection embolizes, or clots,  hypervascular tumors, and prevents blood from flowing in peripheral blood vessels undergoing a bleed or hemorrhage.

Initiated by Boston Scientific on February 20, 2024, the corrective recall covers 1,594 units of Obsido Comformable Embolic that were distributed across the U.S. between May 8, 2023 and February 8, 2024. Officials took action after an investigation found that patients who are administered the Obsidio Embolic using the aliquot technique, a common delivery method in embolization for lower gastrointestinal bleeding, run a high risk of suffering bowel ischemia.

For this reason, the company advises healthcare providers and patients with vascular bleeding against the use of the aliquot technique in the delivery of Obsidio Embolic for procedures involving lower GI bleed embolization.

The most severe, as well as the most common, adverse health outcome has been identified as been a condition that requires significant surgery, like “bowel resection and/or diverting colostomy.” Users who implement the product to carry out the aliquot technique should be aware that blood and oxygen flow to organs, such as the small bowel (ischemia), may be obstructed and cause “non-target embolization.” Such a condition may lead to a longer hospital stay, an additional surgery, or even death.

At the time of the FDA announcement, Boston Scientific has received 11 incident reports, 7 reports of injuries, and 2 reports of deaths in connection to the issue.

An Urgent Medical Device Product Advisory was sent to Boston Scientific customers on February 21, 2024 to advise against use of the aliquot technique “for lower GI bleed embolization procedures with Obsidio Embolic” because of the heightened risks.

Healthcare providers and facilities were urged to display the notice prominently and near the product to ensure all users are made aware of the advisory.

Other recall-related questions may be directed to a customers’s local Boston Scientific representative.

As the FDA continues to monitor this recall, the agency urges all healthcare professionals and consumers to report any related adverse events to its MedWatch program.


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