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U.S. Department of Health and Human Services

Class 2 Device Recall Sophysa Pressio ICP Monitoring System

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  Class 2 Device Recall Sophysa Pressio ICP Monitoring System see related information
Date Initiated by Firm April 09, 2024
Date Posted May 15, 2024
Recall Status1 Open3, Classified
Recall Number Z-1825-2024
Recall Event ID 94464
510(K)Number K062584  K162108  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
Product 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
Code Information UDI-DI: 03760124131482 OUS Serial Numbers: 22C02558 22C02582 22C07751 22C07753 22C09753 22C09757 22C09772 22C09780 22C09781 22C09783 22C09850 22C11644 22C13089 22C14035 22C14036 22C14151 22C14152 22C14153 22C14154 22C14156 22C14158 22C14159 22C14165 22C14166 22C14167 22C14171 22C14172 22C14173 22C14174 22C14178 23C02554 23C03278 23C03279 23C03280 23C03281 23C03282 23C03283 23C03284 23C03285 23C03286 23C03287 23C03288 23C03289 23C03290 23C03291 23C03295 23C03302 23C03308 23C03310 23C03314 23C03315 23C03316 23C03317 23C07704 23C07710 23C07718 23C60201 23C60202 23C60203 23C60209 23C60210 23C60211 23C60212 23C60227 23C60232 23C60233 23C60240 23C60270 23C60271 23C60273 23C60275 23C60276 23C60277 23C60278 23C60282 23C60283 23C60284 22C22761 22C33393 22C33394 22C33395 22C33396 22C33397 22C33398 22C33642 22C41544 22C41545 22C41546 22C41547 22C41548 22C41553 22C41554 22C41557 22C41558 22C41560 22C41810 22C41811 22C41812 22C41813 22C41814 22C41815 22C41817 22C41818 22C41820 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Recalling Firm/
Manufacturer		 Sophysa S.A.
5 Rue Guy Moquet
Orsay France
For Additional Information Contact
(0)69353500
Manufacturer 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.
FDA Determined
Cause 2		 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 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
Quantity in Commerce 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, SWEDEN, VIETNAM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GWM and Original Applicant = SOPHYSA SA
510(K)s with Product Code = GWM and Original Applicant = SOPHYSA, SA
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