In May, 2019, the U.S. Food and Drug Administration (FDA) announced a class I recall of Integra LifeSciences’ LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and its MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems. A class I recall is the most serious type of recall in which the recalled product poses a serious risk of harm or death to the patient. Due to the nature of the devices and their use, patients may not be aware that the device was used during their procedure. The defective devices have the potential to cause infection, brain injury and death.
Defective Intracranial Devices
The recalled devices are used to drain excess cerebrospinal fluid from the brain and lumbar subarachnoid space, and to monitor pressure in the brain. Over 42,000 units were recalled after multiple complaints of the device breaking. According to the FDA, serious injuries have been reported.
Intracranial Device Injuries
When the devices fail, too much fluid can be drained and/or air can flow back into the space. The result can be serious injury or death. According to the FDA, failure of the LimiTorr and MoniTorr Drainage Systems can cause:
- Subdural hematoma
- Brain herniation – shifting of the brain tissue from one space in the brain to another
- Pneumocephalus – gas trapped within the cranial cavity
If you believe that your injuries or the death of a loved one may have been caused by a defective intracranial medical device, please schedule a free consultation with an experienced product liability attorney right away to learn more about your rights.