Z-1826-2024.jsonld
type: Dataset
name: 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
description: FDA recall Z-1826-2024 — Sophysa S.A. is recalling 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 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: 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
  manufacturer: Sophysa S.A.
claims: enforcement-record
claims: FDA classified recall Z-1826-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1826-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1826-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Sophysa S.A.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-04-09
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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 22D009…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: 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.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1826-2024: Sophysa S.A. is recalling 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
text: The FDA logged enforcement record Z-1826-2024: Sophysa S.A. is voluntarily recalling 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 — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-09. Affected lots/codes: 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 …
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-1826-2024 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.