Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System Recalled by Codman & Shurtleff, Inc. Due to Incorrect instructions for use (IFU).
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Codman & Shurtleff, Inc. directly.
Affected Products
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
Quantity: 3,860
Why Was This Recalled?
Incorrect instructions for use (IFU).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Codman & Shurtleff, Inc.
Codman & Shurtleff, Inc. has 58 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report