Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is Recalled by Sophysa S.A. Due to An increase in claims related to leakage of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sophysa S.A. directly.
Affected Products
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
Quantity: 3487 units OUS
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sophysa S.A.
Sophysa S.A. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report