TRUFILL® Liquid Embolic System Recall

January 23, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall for the TRUFILL n-BCA Liquid Embolic System because incorrect instructions on mixing ratios could cause patients to suffer a pulmonary embolism (blood clot in the lungs), brain damage, or even death.

The manufacturers of Liquid Embolic System are Codman Neuro and DePuy Synthes (companies of Johnson & Johnson). They identified the problem through routine internal correction procedures, sent a correction notice (.pdf) to customers in October 2013, and informed that FDA and other health authorities. The FDA believes this constitutes a Class 1 recall, meaning that there is a reasonable probability that the defect can cause severe injury or death.

The TRUFILL n-BCA Liquid Embolic System is used for embolization of cerebral arteriovenous malformations (AVMs) before surgery. AVMs are abnormal connections between veins and arteries in the brain, which can cause headaches, seizures, weakness, numbness, vision changes, excruciating pain, and intracranial hemorrhage.

To treat AVMs, doctors use a product to block the blood supply to a part of the body. The Liquid Embolic System uses a 2:1 ratio (67% Ethiodized Oil / 33% nBCA). If higher concentrations of ethiodized oil are used in areas of high blood flow-rates, this could result in blockages farther away from the intended site, resulting in severe patient injury.

According to Codman Neuro:

“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.”

Despite the severity of the problem and the Class 1 recall, the company is not withdrawing affected products from the market. Instead, they are informing physicians of the correct instructions. Products included in the recall were manufactured between February 25, 2010 and October 31, 2013.

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