FDA designates Class 1 recall for cranial drill

Editor's Note

The US Food and Drug Administration (FDA) has designated Integra LifeSciences’ recall of specific Codman Disposable Perforators and Craniotomy Kits a Class 1, the most severe category indicating serious risk of injury or death.

As detailed in the agency’s July 16 announcement, the recall of the single-use cranial drills, which are designed to automatically disengage after drilling, was motivated by an inadequate ultrasonic weld on the outer sleeve that could cause disassembly or failure to disengage and stop immediately. Risks include damage to the dura, bleeding, brain injury, extended surgery, irreversible brain damage, and death.

FDA reports zero deaths and 10 injuries, “including those from procedural delay, device becoming lodged in the patient’s skull during use, difficulty removing device fragments, bleeding, dural injury, and cerebral injury.” Among other instructions, an April letter from Integra LifeSciences advises customers to review inventory, stop using and quarantine all affected product, and return affected product to the company.