Codman & Shurtleff, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0789-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: October 11, 2013

Date Posted: January 29, 2014

Recall Number: Z-0789-2014

Event ID: 66493

Reason for Recall:

Incorrect instructions for use (IFU).

Status: Terminated

Product Quantity: 7,983

Code Information:

All lot codes

Distribution Pattern:

Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.

Voluntary or Mandated:

Voluntary: Firm initiated