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
Recall
- Recall Number
- Z-1825-2024
- Event Number
- 94464
- FEI Number
- 3001587388
- Product Code
- GWM
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- April 9, 2024
- Posted
- May 15, 2024
- Address
- Sophysa S.A. 5 Rue Guy Moquet Orsay France
Description
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
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.
Sophysa issued Urgent Product Recall Letter dated 4/9/24 via email. Letter states reason for recall, health risk and action to take: 1- Please stop using the listed products immediately and remove all affected units from your inventory, 2- Please inform the healthcare professionals at your facility who use these products, 3- Isolate the units concerned in a safe place for return to Sophysa 4- Please complete the enclosed Acknowledgement Form, even if you are no longer in possession of the products to be returned. And return it to Sophysa [email protected] no later than April 15, 2024. 5- If you have products to return, please pack them in an appropriate shipping box. Upon receipt of the verification form, Sophysa will contact you to arrange the return of the products
Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the countries of ARGENTINA, CHINA, CZECH REPUBLIC, FRANCE, GREECE, HUNGARY, JAPAN, PAKISTAN, Portugal, ROMANIA, SOUTH AFRICA, SWEDEN, VIETNAM.
3487 units OUS