TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
FDA Recall Z-0789-2014 · Posted 2014-01-23
Recalling FirmCodman & Shurtleff, Inc.
Recall StatusTerminated
Product CodeKGG
Date Initiated2013-10-11
Date Terminated2015-07-28
Product Quantity7,983
Reason for Recall
Incorrect instructions for use (IFU).
Firm Action
The firm, CODMAN Neuro, sent a "Medical Device Correction Notice" letter dated October 21, 2013 to its consignees/customers. The letter describes the product, problem and actions taken. The letter informed the consignees/customers of the incorrect statement in the IFU. The Corrected IFU was provided. Codman Neuro is in the process of updating the Instructions for Use to include the corrected information. Consignees/customers were instructed to complete and return the Correction Notice Acknowledgement Form and fax it to Codman Neuro at 508-977-6665.
For additional information, please contact Codman Neuro representative at 1-866-491-0974.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.