Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit Recall Due to CSF Leakage Risk
Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to manufacturing defects causing cerebrospinal fluid leakage from the catheter. Undetected leaks during implantation could result in infection risk to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a manufacturing defect creating risk-of-harm through potential CSF leakage and subsequent infection. No specific illnesses or injuries are documented in the source text, placing this at High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit (PSO-VT) is a medical device intended for monitoring intracranial ventricular pressure and cerebrospinal fluid drainage applications.
An increase in claims related to cerebrospinal fluid (CSF) leakage from the proximal end of the catheter has been reported. The manufacturer has identified the cause as a manufacturing error involving perforation of the inner channel of the catheter during stylet insertion. If a leak goes undetected during implantation, it could pose an infectious risk to the patient.
The recall affects 3,487 units distributed outside the United States to the following locations: Arizona, New York, and Texas within the United States, and internationally to Argentina, China, Czech Republic, France, Greece, Hungary, Japan, Pakistan, Portugal, Romania, South Africa, Sweden, and Vietnam.
Patients or healthcare providers with questions about this device should contact Sophysa S.A. or their healthcare provider for guidance on device management.
The recalled product
- 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.…
- Manufacturer
- Sophysa S.A.
- Affected units
- 3,487
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sophysa S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Sophysa S.A.
See all →- HighSophysa Pressio Ventricular ICP Monitoring Kit Recalled for Manufacturing Defect Causing CSF Leakage
FDA (Devices) · 2024-05-22
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