In May 2019, the USFDA announced a class Ⅰ recall of Integra LifeScience’s LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and its MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems.
Class Ⅰ recalled products poses a serious risk of harm or death to the patient that’s why these recalls are considered as the most serious ones. Defective devices have the potential to cause infection, brain injury and death. The patients may not be aware about the device as it is used by the clinicians.
The recalled devices are used to drain excess CSF from the brain and lumbar subarachnoid space, and to monitor pressure in the brain. After receiving multiple complaints about the breaking of the device, 42000 units were recalled. The FDA also informed that serious injuries have been reported as well.
The devices failure can lead to drainage of too much fluid or air can flow back into the space and can result in serious injuries such as meningitis, ventriculitis, brain herniation etc., and death in some cases.
The people can consult with an experienced product liability attorney to learn about their rights against such adverse incidents.
Mr Vinod Arora, Principal Advisor, IGMPI
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