Recall Class: Class I
Date Recall Initiated: Oct. 11, 2013
Product: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System containing TRUFILL n-Butyl Cyanoacrylate (n-BCA), TRUFILL Ethiodized Oil, and TRUFILL Tantalum Powder
These components must be used as a system. They are not intended to be used as individual components.
TRUFILL n-BCA Liquid Embolic System product codes associated with this recall include the following (all lots):
|631400||Two 1 gram tubes nBCA|
|631500||One 1 gram tube nBCA|
The affected products were distributed from February, 2010 through October, 2013.
Use: TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformation (AVMs) when pre-surgical devascularization is desired.
Codman Neuro (formerly Codman & Shurtleff, Inc.)
325 Paramount Drive
Raynham, Massachusetts 02767
Reason for Recall: The product instructions contain an incorrect statement in the Instructions for Use. The use of the incorrectly mixed product can result in the liquid mixture solidifying too slowly in the intended areas, and unintended embolization or reflux into arteries and pulmonary vessels. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
Public Contact: For questions or additional information, customers can contact their Codman Neuro representative. Report any malfunction or adverse event related to this device to Codman Neuro on weekdays between 7:00 a.m. and 6:30 p.m. Eastern Time at 1-866-491-0974, Option 2.
FDA District: New England District Office
On October 21, 2013, the firm sent a Medical Device Correction Notice to U.S. and international customers informing them of the incorrect statement in the Instructions for Use (IFU) as well as the corrected IFU.
The Instructions for Use incorrectly stated:
"A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injection within ½ second."
The correct information should have stated:
"A 2:1 (67% Ethiodized Oil / 33% nBCA) for Intranidal injections without AV fisulae or high flow rates in order to more deeply penetrate the nidus."
TRUFILL n-BCA Liquid Embolic System is not being removed from the market. Codman Neuro is in the process of updating their Instructions for Use as indicated in the tables found in the Medical Device Correction Notice which show both the incorrect and corrected Table 4 contents .
Thorough product training is required before purchasing the TRUFILL n-BCA Liquid Embolic System. All customers who have purchased TRUFILL nBCA are reminded to review the correction notice and other product literature to ensure proper mixing procedures are followed. Codman Neuro has verified that all related physician training materials and other documents (e.g., brochures) contain correct information.
Customers were asked to complete an acknowledgement form and fax it to Codman Neuro at 508-977-6665.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.