FDA Classifies Worldwide Voluntary Correction Notice on TRUFILL® n-BCA Liquid Embolic System as Class I Recall
RAYNHAM, Mass. – January 21, 2014 – Codman Neuro announced today that the U.S. Food and Drug Administration (FDA) has classified the recently initiated medical device correction notice related to the TRUFILL® n-BCA Liquid Embolic System as a Class I recall.
TRUFILL® n-BCA is indicated for embolization of cerebral arteriovenous malformations (AVMs) when presurgical devascularization is desired. 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. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
In October 2013, Codman Neuro identified an incorrect statement in the product’s Instructions For Use (IFU) that described suggested mixing ratios for use in certain treatment conditions, informed the U.S. Food and Drug Administration and other regulatory authorities, and issued a corresponding correction notice to inform customers in the U.S., Costa Rica, Puerto Rico and Russia. The error was identified through routine internal procedures.
Product is not being removed from the market. The company is informing physicians of this incorrect statement and updating the product’s 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 correct information should have stated: “A 2:1 (67% Ethiodized Oil / 33% nBCA) for Intranidal injections without AV fistulae or high flow rates in order to more deeply penetrate the nidus.”
No corresponding patient deaths or permanent patient injuries have been reported to date. When the product is mixed correctly, it is expected to perform as intended. Thorough product training is required before purchasing the TRUFILL® nBCA. The company has verified that all related physician training materials and promotional documents contain correct information.
All customers who have purchased TRUFILL® nBCA are reminded to review the correction notice and other product literature to ensure proper mixing procedures are followed. They may also call Codman Neuro with questions or to report any malfunction or adverse event on weekdays between the hours of 7:00am and 6:30pm Eastern Time at 1-866-491-0974, Option 2.
TRUFILL® nBCA products associated with the correction notice were manufactured between February 25, 2010 and October, 31, 2013, distributed to hospitals and surgical centers, and include the following codes (all lots):