Class II — Sophysa S.A.
| Recalling firm | SOPHYSA |
|---|---|
| Registered facility | SOPHYSA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 |
| Quantity | 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. |
| Initiated | 2024-04-09 |
| Classified | 2024-05-15 |
| Recall number | Z-1826-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sophysa S.A. (Z-1826-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94464/
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