FDA classifies worldwide voluntary correction notice on Trufill at Class I Recall

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Codman Neuro announced that the US 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.

According to a press release, Trufill n-BCA is indicated for embolisation of cerebral arteriovenous malformations (AVMs) when presurgical devascularisation is desired. The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolisation 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 US Food and Drug Administration and other regulatory authorities, and issued a corresponding correction notice to inform customers in the US, Costa Rica, Puerto Rico and Russia. The error was identified through routine internal procedures. The product is not being removed from the market, the press release reports.

The company is informing physicians of this incorrect statement and updating the product’s Instructions For Use. The product’s Instructions For Use 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.”

The press release adds, 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.