PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 22, 2024 Initiated: April 9, 2024 #Z-1826-2024

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.

Details

Recalling Firm
Sophysa S.A.
Units Affected
3175 units- 41 units US; 3134 units OUS
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.
Location
Orsay, N/A

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Sophysa S.A.. Units affected: 3175 units- 41 units US; 3134 units OUS.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1826-2024.

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