Sophysa S.A. Recall: The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit
Sophysa S.A. Recall: The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sophysa S.A.; Product: The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ven
| Recalling firm | Sophysa S.A. |
|---|---|
| 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 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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. |
| Recall initiated | 20240409 |
| Recall number | Z-1826-2024 |
| Category | device |
| State | N/A |
| Country | France |
$29/mo
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