Reported May 22, 2024 · Ongoing
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring…
Sophysa S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sophysa S.A. · 5 Rue Guy Moquet · Orsay, N/A · N/A
Is this the product you have?
- 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 NumberPSO-VT
- Lot codes and dates
- UDI-DI03760124131482
- OUS Serial Numbers
3,487 of 3,487 codes
22C0255822C0258222C0775122C0775322C0975322C0975722C0977222C0978022C0978122C0978322C0985022C1164422C1308922C1403522C1403622C1415122C1415222C1415322C1415422C1415622C1415822C1415922C1416522C1416622C1416722C1417122C1417222C1417322C1417422C1417823C0255423C0327823C0327923C0328023C0328123C0328223C0328323C0328423C0328523C0328623C0328723C0328823C0328923C0329023C0329123C0329523C0330223C0330823C0331023C0331423C0331523C0331623C0331723C0770423C0771023C0771823C6020123C6020223C6020323C60209
- Amount recalled
- 3487 units OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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