Boston Scientific Updates on the Use of Vascular Embolization Devices: A Correction Overview

This recall pertains to updating the operational instructions for these devices and does not involve their removal from sale or distribution. The FDA has categorized this recall as the most critical type. Failure to adhere to the revised instructions may result in severe injury or even death.
UPDATE – Friday, October 11, 2024:
Boston Scientific has released an updated set of instructions for the use of this device. This revision follows earlier guidance issued on February 20, 2024.
Product Details
- Product Name: Obsidio Conformable Embolic
- Product Codes: Access Medical Device Recall Database
- Distribution Dates: May 8, 2023 to February 8, 2024
- Total Devices Recalled in the U.S.: 1,594
- Recall Initiated by Company: February 20, 2024; Updated October 11, 2024
Recommended Actions
Adhere to the updated operational instructions. On October 11, 2024, Boston Scientific distributed an urgent advisory letter to all impacted customers outlining the following recommendations:
- Consult the new labeling updates for the Obsidio Conformable Embolic, which include:
- Avoid using the aliquot technique or pushing Obsidio Embolic with saline, which is a standard method for delivery in embolization procedures when treating any gastrointestinal (GI) bleeding with this device.
- Avoid forceful injections in or around the Obsidio Embolic. These could alter its properties and increase the likelihood of off-target embolization.
- Strictly follow the revised instructions provided in the Recommended Procedure section of the labeling.
Rationale for Instruction Updates
Boston Scientific is revising the usage instructions for the Obsidio Conformable Embolic due to safety concerns associated with its use in the GI region. Previously reported serious adverse health issues tied to lower GI bleeding have expanded to encompass all GI bleeding.
Utilizing this product through the aliquot method or pushing with saline may lead to off-target embolization, ischemia (disruption of blood and oxygen flow to organs) in the small bowel, potentially resulting in extended hospital stays, additional surgical interventions like bowel resection or colostomy, or even death.
Boston Scientific advises against modifying the Obsidio Embolic with the aliquot technique or saline pushing.
There have been reported fifteen injuries and four fatalities associated with this concern.
Device Purpose
The Obsidio Conformable Embolic serves as a pre-mixed embolic agent, designed for minimally invasive delivery to occlude blood flow to targeted blood vessels. Once administered, the Obsidio Conformable Embolic forms a solid mass within the vessel, stopping blood circulation. Its intended use is for singular applications to embolize hypervascular tumors and to block blood flow from peripheral vessels that are bleeding.
Contacting Boston Scientific
U.S. customers with inquiries regarding this recall are encouraged to reach out to their local Boston Scientific representative.
FDA Information Links:
Unique Device Identifier (UDI)
The unique device identifier (UDI) facilitates the identification of individual medical devices sold in the U.S. throughout the manufacturing and distribution processes to patient application. This identifier enhances accurate reporting, assessment, and analysis of adverse event reports, enabling quicker identification of the device and resolution of issues when they arise.
Reporting Issues
Health care professionals and consumers are encouraged to report adverse reactions or quality concerns related to these devices through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.