CLASS I Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
Trufill¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System recalled
Codman & Shurtleff is recalling Trufill¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, distributed nationwide in the US. The recall was initiated on 11 Oct 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0788-2014
- FDA event ID
- 66493
- Recalling firm
- Codman & Shurtleff, Raynham, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Oct 2013
- FDA classified
- 23 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Oct 2013 | Recall initiated by company | |
| 23 Jan 2014 | Classified by FDA | +104 days |
| 29 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect instructions for use (IFU).
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
Questions about this recall
Is Trufill¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System recalled?
Yes. Codman & Shurtleff recalled Trufill¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System on 11 Oct 2013. The recall is Class I and its status is Terminated. Recall number Z-0788-2014.
Why was it recalled?
Incorrect instructions for use (IFU).
Which lots are affected?
All lot codes
Where was it sold?
Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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