The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit… — Class II medical device recall Z-1825-2024
Ongoing recall by Sophysa S.A., reported 2024-05-22, distributed nationwide. An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. I
| Recall number | Z-1825-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sophysa S.A., Orsay, N/A, France |
| Recall initiated | 2024-04-09 |
| Classified | 2024-05-15 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CN, CZ, FR, GR, HU, JP, PK, PT, RO, SE, VN, ZA |
| Quantity | 3,487 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 03760124131482 |
| Serial numbers | 22C00014, 22C00028, 22C00035, 22C00036, 22C00037, 22C00038, 22C00042, 22C00043, 22C00045, 22C00049, 22C00050, 22C00051, 22C00052, 22C00053, 22C00055, 22C00289, 22C00290, 22C00293, 22C00296, 22C00297, 22C00299, 22C00301, 22C00308, 22C00459, 22C00460 and 475 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1825-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.