Liquid Embolic System Recall Issued Due to Pulmonary Embolism Risk

Incorrect instructions for the TRUFILL n-BCA liquid embolic system could lead to patients suffering a pulmonary embolism or even death, the FDA warns.  

A TRUFILL n-BCA recall was announced by the FDA on January 22, after determining that a medical device correction notice sent out by the manufacturer constitutes a Class I medical device recall. The class I designation is the most severe medical device recall warning, suggesting that the FDA believes the problem carries a reasonable probability of causing severe injury or death to patients.

The TRUFILL n-BCA is used for embolization of cerebral arteriovenous malformations (AVMs) before surgery. However, the manufacturer, Codman Neuro, issued a warning to its customers late last year that indicated there was an incorrect statement in the product’s instructions on mixing rations for some treatment conditions.

The company warns that “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 company notes that the incorrect mixing could lead to a pulmonary embolism, neurological deficits and possibly death. The company did not say whether there had been any adverse events, injuries or deaths reported.

Despite the FDA’s designation of the warning as a Class I recall, the company says it is not removing the affected products from the market, which includes TRUFILL n-BCA liquid embolic system products’ manufactured between February 25, 2010 and October 31, 2013 with product codes 631400 and 631500, affecting two 1 gram tubes nBCA, and one gram tube nBCA products respectively.

Instead, the company is informing physicians of the incorrect instructions and updating them with the correct information.

Customers with questions or who have experienced an adverse event can contact Codman Neuro by calling (8660 491-0974 and selecting Option 2. Adverse events should also be reported to the FDA’s MedWatch adverse event reporting program.