Integra LifeSciences’ April 11, 2025 recall of some Codman disposable perforators and craniotomy kits has been deemed Class I by the U.S. Food and Drug Administration. The recall involves removing certain devices from where they’re used or sold.

Codman disposable perforators are single-use surgical tools for neurosurgical procedures to drill access holes in the skull. They’re engineered to automatically disengage once drilling is finished.

The select products were recalled because of an inadequate ultrasonic weld—a “proud weld”—on the device’s outer sleeve. The defect can cause the perforator to disassemble before, during, or after a craniotomy procedure. In some instances, it may fail to disengage, preventing the device from stopping completely.

Using the affected product can cause damage to the dura, bleeding, brain injury, extended surgery, irreversible brain damage, and death. 10 injuries have been reported 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.

There have been no deaths at the time of report.

In its Aprill 11 Urgent Medical Device Recall Notification, Integra urged customers to immediately cease using and quarantine all affected products. Users were also recommended to review inventory and identify impacted lot numbers.

Affected product should be returned after receiving a Return Material Authorization (RMA), after which credit will be given for providing affected lots.