The FDA has classified the recent device correction notice for TRUFILL n-BCA as a Class I recall. TRUFILL n-BCA is a device used for the treatment of Arterio-Venous Malformations, such as abnormal connection between the arteries and veins in the brain. It is marketed by Codman Neuro, which is part of DePuy Synthes Companies.
Codman Neuro has identified an incorrect statement in the product’s Instructions for Use. The statement could lead to incorrectly mixed product, which in turn could cause serious harm to the patient, such as “neurological deficits, pulmonary emboli and possibly death.” Due to the risk of serious health consequences, the device recall was “Class I” – the most serious type of recall. TRUFILL® nBCA products affected are those manufactured between February 25, 2010 and October, 31, 2013.
So far, no related deaths or permanent injuries have been reported. Customers who have purchased TRUFILL® nBCA must “review the correction notice and other product literature to ensure proper mixing procedures are followed.”