Official recall record
The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure (ref Z-1826-2024)
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-04-09
- Country of alert
- France
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 3760124132922
- Brand on record
- Sophysa S.A.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2024-04-09 · US FDA — Medical Devices
The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring int
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