FDA: Class I recall of Integra LifeSciences CSF drainage, ICP monitoring systems

Editor's Note

The Food & Drug Administration on May 24 identified the recall by Integra LifeSciences of its LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring System as Class I, the most serious.

The recall was initiated because of reports of breakage of the LimiTorr transducer and the MoniTorr panel mount stopcock. Serious patient injuries associated with infection and CSF leakage have been reported.

The devices are used to monitor ICP and to drain CSF from the brain or provide temporary drainage of CSF in patients with infected CSF shunts. The devices also are used to control drainage of CSF from the lumbar subarachnoid space.

Manufacturing and distribution dates for the recalled devices are March 1, 2017, to March 31, 2019.