Recall Z-1826-2024— Sophysa S.A.

Name: FDA recall Z-1826-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-09

Class II · Ongoing

Class II FDA medical device recall by Sophysa S.A., initiated 2024-04-09. It names 2 FDA 510(k) clearances: K162108, K062584. Product: The 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/Catalog Number: PSO-VTT. Reason: 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..

Recalling firm: Sophysa S.A.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-09
Firm location: Orsay, N/A, France

510(k) clearances named in this recall

2 on FDA's record

K162108 — Pressio 2 ICP Monitoring SystemSophysa SA·cleared 2017-04-17
K062584 — PRESSIO ICP MONITORING SYSTEMSophysa SA·cleared 2007-07-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The 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/Catalog Number: PSO-VTT

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.