Z-0788-2014Class I

TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of...

Name: Z-0788-2014 TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of...
Creator: Codman & Shurtleff, Inc.
Published: 2013-10-11
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2013-10-11 / Terminated / root cause: manufacturing process

FDA source

Codman & Shurtleff, Inc. began a recall of 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... on 2013-10-11. FDA classified it as Class I and gives the reason as "Incorrect instructions for use (IFU)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0788-2014
Classification: Class I
Status: Terminated
Initiated: 2013-10-11
Posted: 2014-01-23
Terminated: 2015-07-28
Recalling firm: Cerenovus, Inc.
Product: 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.
Product code: KGG Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
Reason for recall: Incorrect instructions for use (IFU).
Root cause tag: manufacturing process
FDA root cause: 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: 3,860
Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0788-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0788-2014	Class I	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23
Z-0789-2014	Class I	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code KGG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)