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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-1826-2024
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 and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application.
Model/Catalog Number: PSO-VTT
Code Information UDI-DI: 3760124132922 US Serial Numbers: 22D06059 22D06060 22D06745 22D06747 22D06749 22D07240 22D07242 22D07243 22D07246 22D07249 22D07250 22D07251 22D07257 22D08435 22D08436 22D08438 22D08511 22D08512 22D08522 22D08525 22D08526 22D08527 22D08528 22D08529 22D12007 22D12009 22D12012 22D12013 22D12014 22D12016 22D12017 22D12018 22D12019 22D12020 22D12021 22D12022 22D12023 22D12024 22D12025 22D12027 22D12032 OUS S/N: 22D04871 22D04873 22D04875 22D04877 22D04881 22D04907 22D04908 22D04909 22D05006 22D05021 22D09368 22D09376 22D09377 22D09378 22D09379 22D09380 22D09381 22D09382 22D09383 22D09384 22D52761 22D52764 21D20346 21D20353 21D20355 21D20361 21D20367 21D42206 21D42212 21D42215 21D42240 22D00060 22D00064 22D00065 22D00066 22D00067 22D00068 22D00069 22D00070 22D00071 22D00072 22D00074 22D00075 22D00076 22D00077 22D00084 22D00124 22D00240 22D00241 22D00242 22D00244 22D00245 22D00247 22D00248 22D00253 22D00256 22D00258 22D00259 22D00262 22D00263 22D00264 22D00265 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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 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.
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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