The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring…
Medical device recall Z-1826-2024. Published in FDA’s Enforcement Report on May 22, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 22, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 3175 units- 41 units US; 3134 units OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
3175 units- 41 units US; 3134 units OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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 22D00267 22D00269 22D00271 22D00276 22D00277 22D00278 22D00279 22D00286 22D00290 22D00292 22D00297 22D00298 22D00299 22D00301 22D00302 22D00304 22D00307 22D00310 22D00313 22D00315 22D00616 22D00621 22D00622 22D00636 22D00637 22D00638 22D00640 22D00643 22D00645 22D00649 22D00650 22D00661 22D00665 22D00666 22D00667 22D00668 22D00670 22D00671 22D00672 22D00673 22D00674 22D00675 22D00676 22D00677 22D00678 22D00679 22D00680 22D00681 22D00682 22D00683 22D00684 22D00685 22D00686 22D00687 22D00690 22D00691 22D00692 22D00736 22D00746 22D00770 22D00771 22D00772 22D00773 22D00775 22D00776 22D00777 22D00778 22D00780 22D00781 22D00782 22D00783 22D00841 22D00844 22D00845 22D00847 22D00848 22D00850 22D00851 22D00853 22D00854 22D00855 22D00857 22D00858 22D00861 22D00865 22D00866 22D00867 22D00873 22D00875 22D00876 22D00940 22D00952 22D00953 22D00954 22D00955 22D00956 22D00957 22D00959 22D00960 22D00961 22D00962 22D00963 22D00964 22D00965 22D00966 22D00967 22D00968 22D00969 22D00970 22D00971 22D00973 22D00978 22D00979…
FDA’s list runs to 28,624 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Arizona
- New York
- Texas
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 9, 2024.
- FDA classified it on May 15, 2024.
- FDA’s Enforcement Report published it on May 22, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Sophysa S.A., of Orsay, France.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 28,624 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.