The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial

FDA device recall Z-1825-2024 · posted 2024-05-15 · Open, Classified

Recall details

Recalling firm

Sophysa S.A.

Reason for recall

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.

Action taken

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 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

Root cause

Process change control

Status

Open, Classified

Product code

GWM

Quantity affected

3487 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, SWE

Date initiated

2024-04-09

Date posted

2024-05-15

Location

Orsay, France

Related 510(k) clearances