The U.S. Food and Drug Administration (FDA) has labeled Codman Neuro’s recall of Trufill n-BCA liquid embolic system as High Risk Class I. Codman Neuro is a division of Johnson & Johnson’s subsidiary DePuy Synthes.
Codman Neuro said it identified the error at the end of October last year through routine internal procedures. An incorrect mixing ratio suggestion was stated in the product’s Instructions for Use (IFU) for treatment of certain conditions.
The Trufill n-BCA liquid embolic system was designed to treat abnormal connections between veins and arteries in the brain. The drug is used to embolize cerebral arteriovenous malformations (AVMs) in cases when presurgical devascularization is required. The incorrect statement read “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” instead of the correct “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.”
Use of incorrectly mixed product can lead to the liquid mixture solidifying into embolisms or reflux into arteries and pulmonary vessels. The error could possibly lead to pulmonary emboli, neurological deficits or death.
The company alerted the FDA and other regulatory authorities of the error. Codman Neuro also issued corresponding correction notices to its customers in Russia, Puerto Rico, Costa Rica, and the U.S. The company said no patient deaths or permanent injuries have been reported to date.
The classification is FDA’s highest risk label for recalls. Product recalls range from the lowest risk, such as medical device safety alerts, to Class III, II, and I recalls. Class I recalls concern situations in which there is a reasonable possibility that use of a violative product will result in serious adverse health consequences and even death.
Affected lots were identified under 631400 and 631500 product codes. The recalled lots were manufactured from February 2010 to October 2013. Codman Neuro encouraged physicians to report any malfunctions, but the product is not being removed from the market.