# FDA recall Z-1825-2024

> **Sophysa S.A.** · Class II · device recall initiated 2024-04-09.

## Product

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

## 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.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the countries of  ARGENTINA, CHINA, CZECH REPUBLIC, FRANCE, GREECE, HUNGARY, JAPAN, PAKISTAN,  Portugal, ROMANIA, SOUTH AFRICA, SWEDEN, VIETNAM.

## Key facts

- **Recall number:** Z-1825-2024
- **Recalling firm:** Sophysa S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-09
- **Report date:** 2024-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orsay, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2024

## Citation

> AI Analytics. FDA recall Z-1825-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1825-2024. Source: US FDA. Licensed CC0.

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