Recall Z-1826-2024 ยท GWM Device, Monitoring, Intracranial Pressure
Sophysa S.A.
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 application. Model/Catalog Number: PSO-VTT
| Date | May 15, 2024 (initiated Apr 9, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| Action | 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 contact@sophysa.us no later than April 15, 2024. 5- If y |
| Quantity | 3175 units- 41 units US; 3134 units OUS |
| Distribution | 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. |
| FDA record | Open on fda.gov |