Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall
MedSun: Newsletter #92, February 2014

FDA MedWatch Safety Alert

Codman Neuro is informing physicians of this incorrect statement and updating the product's Instructions For Use (IFU). The product's IFU incorrectly noted: "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 injections within 1/2 second." The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels.

Additional Information:

Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall. FDA MedWatch Safety Alert. January 22, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382556.htm


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