TRUFILL¿ n-Butyl Cyanoacrylate — Class I medical device recall Z-0788-2014
Terminated recall by Codman & Shurtleff, Inc., reported 2014-01-29, distributed nationwide. Incorrect instructions for use (IFU).
| Recall number | Z-0788-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Codman & Shurtleff, Inc., Raynham, MA, United States |
| Recall initiated | 2013-10-11 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2015-07-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, RU |
| Quantity | 3,860 |
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 for recall
Incorrect instructions for use (IFU).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0788-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.