Integra LifeSciences Corporation has issued an urgent, worldwide recall of its NeuroBalloon Catheter. The FDA is expected to classify the recall as a Class I recall, the most serious since use of the recalled device may lead to death or serious injury. The New Jersey company received eight complaints, none involving injury. However, the malfunction is serious enough to warrant an immediate recall. Upon inspection of the catheter, a defect in the catheter was found. The NeuroBalloon Catheter is designed for use during intracranial procedures.
In July, the company had issued a voluntary recall. Nearly 2,000 catheters have been distributed.