FDAApril 9, 2024device
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
What to do
FDA enforcement status: Ongoing
Brands named
sophysa
UPCs
03760124131482
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAThe Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor2025-11-17
- FDAThe Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Cata...2024-04-09
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