Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding
This recall involves updating instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
UPDATE – Friday, October 11, 2024:
Boston Scientific updated its instructions for use for this device. This update follows previous instructions that Boston Scientific issued on February 20, 2024.
Affected Product
- Product Name: Obsidio Conformable Embolic
- Product Codes: See Medical Device Recall Database Entry
- Distribution Dates: May 8, 2023 to February 8, 2024
- Devices Recalled in the U.S.: 1,594
- Date Initiated by Firm: February 20, 2024; Updated on Friday, October 11, 2024
What to Do
Follow updated use instructions. On Friday, October 11, 2024, Boston Scientific sent all affected customers an updated urgent medical device advisory letter recommending the following actions:
- Refer to new labeling updates for the Obsidio Conformable Embolic including:
- Do not use the aliquot technique or push Obsidio Embolic with saline, a commonly used delivery method in embolization procedures, when performing embolization for any gastrointestinal (GI) bleeding with the Obsidio Conformable Embolic device.
- Do not make forceful injections in or near the Obsidio Embolic. These could change its properties and raise the risk of off-target embolization.
- Do follow the revised instructions included in the Recommended Procedure section of the labeling.
Reason for Updates to Use Instructions
Boston Scientific is updating use instructions for Obsidio Conformable Embolic due to a concern for risks with using this device anywhere in the GI area. Previous serious adverse health consequences were associated with lower GI bleeding. Recent serious adverse health consequences included all GI bleeding.
Use of this product with the aliquot technique or pushing with saline may cause off-target embolization, ischemia (preventing blood and oxygen flow to organs), including of the small bowel, which may lead to prolonged hospitalization, the need for additional surgery such as bowel resection or diverting colostomy, or death.
Boston Scientific does not recommend altering the Obsidio Embolic by using the aliquot technique or pushing with saline.
There were fifteen injuries and four deaths related to this issue.
Device Use
The Obsidio Conformable Embolic is a premixed embolic agent that is delivered minimally invasively to block (occlude) blood flow to specific blood vessels. After injection, Obsidio Conformable Embolic creates a solid cast in the vessel and halts blood flow. It is intended for single use to embolize hypervascular tumors and to block (occlude) blood flow in peripheral blood vessels that are bleeding or hemorrhaging.
Contact Information
Customers in the U.S. with questions about this recall should contact their local Boston Scientific Representative.
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.