January 23, 2013 — The TRUFILL n-BCA Liquid Embolic System is being voluntarily recalled by Codman Neuro because incorrect instructions on the mixing ratio could cause patients to develop a life-threatening pulmonary embolism, neurological deficits, or death.
It is used for pre-surgical treatment of cerebral arteriovenous malformations (AVMs), which are abnormal connections between veins and arteries in the brain. People with AVMs often have severe pain, headaches, seizures, progressive weakness and numbness, and sometimes develop intracranial hemorrhage.
Treatment of AVMs involves blocking abnormal connections between blood vessels in the brain. The Liquid Embolic System uses a 2:1 ratio of Ethiodized Oil (67%) and nBCA (33%). Unfortunately, incorrect instructions may cause physicians to use higher concentrations of ethiodized oil in areas of the brain with high blood flow-rates, which could result in blockages in unintended areas of the body.
Codman Neuro warns:
“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.”
The issue was discovered through routine internal correction procedures, and customers were notified (.PDF) in October 2013. Despite the serious nature of the problem, product is not being withdrawn from the market — rather, physicians are being sent correct instructions.
The U.S. Food and Drug Administration (FDA) classifies this action as a Class 1 recall, the most serious type of recall reserved for products that have a reasonable probability of causing severe injury or death.
The Liquid Embolic System is manufactured by Codman Neuro, which is part of DePuy Synthes and Johnson & Johnson. Products included in the recall were manufactured from February 25, 2010 through October 31, 2013.
Do I have a Liquid Embolic System Lawsuit?
The Schmidt Firm, PLLC is currently accepting TRUFILL n-BCA Liquid Embolic System induced injury cases in all 50 states. If you or somebody you know has been injured by a liquid embolic system, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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