Sophysa Pressio Ventricular ICP Monitoring Kit Recalled for Manufacturing Defect Causing CSF Leakage
Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to a manufacturing defect that causes cerebrospinal fluid leakage. An undetected leak during implantation could pose an infectious 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 device with manufacturing defect causing potential for serious harm. No reported illnesses or injuries have been documented. The hazard involves risk of infection from undetected cerebrospinal fluid leakage in a high-risk patient population (neurosurgical/critical care), meeting the criteria for high-risk products where injury has not yet been reported.
Plain-English summary
Sophysa S.A. is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit (Model PSO-VTT), a device intended for monitoring intracranial ventricular pressure and temperature. The device is recalled due to a manufacturing defect that can cause cerebrospinal fluid leakage from the proximal end of the catheter.
The defect involves a perforation of the inner channel of the catheter that occurs during stylet insertion in the manufacturing process. If a leak goes undetected during implantation, it could pose an infectious risk to the patient.
The recalled units include 41 devices in the United States (Arizona, New York, and Texas) and 3,134 devices distributed internationally in Argentina, China, Czech Republic, France, Greece, Hungary, Japan, Pakistan, Portugal, Romania, South Africa, Sweden, and Vietnam.
The recalled product
- 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…
- Manufacturer
- Sophysa S.A.
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 Intracranial Pressure Monitoring Kit Recall Due to CSF Leakage Risk
FDA (Devices) · 2024-05-22
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