FDA Device recall Z-0788-2014
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- FDA Device
- Class I
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class I recall of TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System by Codman And Shurtleff, citing incorrect instructions for use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0788-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-10-11 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Codman And Shurtleff |
| Distribution | US |
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.
Reason
Incorrect instructions for use (IFU).
Identifiers
| code_info | All lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0788-2014%22
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