The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring…
Medical device recall Z-1825-2024. 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
- 3487 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 with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
3487 units OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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 22C41821 22C41822 22C41824 22C42031 22C42032 22C42033 22C42034 22C42038 22C42040 22C42041 22C57405 22C57408 22C57409 22C57411 22C57412 22C57413 22C58468 22C58469 22C58470 22C58471 22C58472 22C58473 22C58474 22C58477 22C00882 22C00883 22C01603 22C01604 22C01605 22C01606 22C01607 22C02085 22C04231 22C05404 22C05407 22C05492 22C05494 22C05598 22C05599 22C05600 22C59630 22C59631 22C01874 22C05601 22C04267 22C05603 22C59632 22C05403 22C05602 22C05604 22C05405 22C05400 22C59633 22C02888 22C02891 22C03378 22C03380 22C03381 22C03387 22C03388 22C03389 22C03390 22C03391 22C03458 22C03461 22C03464 22C03467 22C03468 22C03469 22C03470 22C03471 22C03472 22C03473 22C03474 22C03475 22C03476 22C03477 22C03478 22C03485 22C08732 22C08733 22C08735 22C08736 22C08737 22C08738 22C08739 22C08740 22C08741 22C08742 22C08745 22C10279 22C10280 22C10283 22C10285 22C10628 22C10632 22C10633 22C10907 22C10909 22C10910 22C10911 22C11574 22C11577 22C11584 22C11589 22C11590 22C11595 23C60204 23C60205 23C60206 23C60213 23C60215 23C60217…
FDA’s list runs to 31,425 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 31,425 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.