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U.S. Department of Health and Human Services

Class 1 Device Recall nButyl Cyanoacrylate (nBCA) Liquid Embolic System

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  Class 1 Device Recall nButyl Cyanoacrylate (nBCA) Liquid Embolic System see related information
Date Initiated by Firm October 11, 2013
Date Posted January 23, 2014
Recall Status1 Terminated 3 on July 28, 2015
Recall Number Z-0789-2014
Recall Event ID 66493
PMA Number P990040 
Product Classification tissue adhesive for use in embolization of brain arteriovenous malformations - Product Code KGG
Product 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.
Code Information All lot codes
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact
866-491-0974
Manufacturer Reason
for Recall		 Incorrect instructions for use (IFU).
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 7,983
Distribution Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = KGG and Original Applicant = Cerenovus, Inc.
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