TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic… recallZ-0789-2014 · Codman & Shurtleff, Inc. · initiated Oct 11, 2013
Class I Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Codman & Shurtleff, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect instructions for use (IFU).
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-0789-2014
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Oct 11, 2013
- Posted by the FDA
- Jan 23, 2014
- Recalling firm
- Codman & Shurtleff, Inc.
- Quantity
- 7,983
- Product code
- KGG
- FDA submissions
- P990040
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
Product description
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 (models, lots, serial numbers)
All lot codes
Other devices under the same FDA submission
2 devices cleared under P990040 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TRUFILL 631-500Cerenovus, Inc. · tissue adhesive for use in embolization of brain arteriovenous malformations26 reports
- TRUFILL 632500NACerenovus, Inc. · tissue adhesive for use in embolization of brain arteriovenous malformations5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 66493).
- Z-0788-2014 · TerminatedTRUFILL 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; …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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