Integra LifeSciences Holdings Corp. recalled several cerebrospinal fluid drainage and monitoring kits due to mechanical problems with some of the components.
The recall covers the LimiTorr volume limiting cerebrospinal fluid drainage system and the MoniTorr intracranial pressure external CSF drainage and monitoring systems. The U.S. Food and Drug Administration said it is a class I recall, the most serious type, as the devices could lead to serious injury or death.
Healthcare providers use the devices to monitor pressure inside the skull, or intracranial pressure, and to drain CSF from the brain to reduce pressure.
The recall was triggered by complaints about breakages in the stopcock, a valve used to control the flow of liquid, and the transducer, which converts energy from one form to another, in the medical devices.
Plainsboro, N.J.-based Integra said serious patient injuries such as infection and CSF leakage, or over-drainage, associated with the device failures had been reported.
No deaths were reported.
The medical equipment maker said 24,587 devices manufactured between March 1, 2017, and March 31, 2019 are being recalled.