Integra LifeSciences is recalling specific Codman Disposable Perforators and Craniotomy Kits due to an inadequate ultrasonic weld on the outer sleeve of the device. This weld defect may cause the perforator to disassemble before, during, or after use in craniotomy procedures. In some cases, the device may fail to disengage, preventing the device from stopping immediately.
The use of affected product may cause serious adverse health consequences, including damage to the dura, bleeding, brain injury, extended surgery, irreversible brain damage, and death.
There have been 10 reported 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. There have been no reports of death.
Device Use
Codman Disposable Perforators are single-use surgical tools used in neurosurgical procedures to drill access holes into the skull. They are designed to automatically disengage once drilling is complete.
The full recall notice is available here.
