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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1165-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.",
  "description": "FDA recall Z-1165-2024 — Medtronic Neurosurgery is recalling Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume. (Devices, Class I). 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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1165-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medtronic Neurosurgery"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1165-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1165-2024: Medtronic Neurosurgery is recalling Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.",
      "text": "The FDA logged enforcement record Z-1165-2024: Medtronic Neurosurgery is voluntarily recalling Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume. — reason: Potential for catheter disconnection   from the patient line stopcock connectors.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-22. Affected lots/codes: Lot Number/GTIN: 221343119 00613994445391; 221612695 00613994445391; 221873429 00613994445391; 221873431 00763000406011; 222082062 00613994445391; 222480771 00763000406011; 222480772 00763000406011; 223565026 00763000624798; 223580361 00763000624798; 223580378 00763000624798; 223618474 00763000624798; 223621056 00763000624798; 223659561 00763000624798; 223907224 00613994445391; 223907225 00613994445391; 223956150 00613994445391; 223999042 00613994445391; 223999043 00613994445391; 224032609 00613994445391; 224128508 00763000406011; 224387126 00763000406011; 224852795 00613994445391; 224852796 00613994445391; 224878536 00613994445391; 224949834 00613994445391; 224949835 00613994445391; 224990657 00763000624798; 224990660 00613994445391; 224990846 00613994445391; 224990847 00763000624798; 224990889 00763000624798; 225198821 00613994445391; 225500036 00613994445391; 225500037 00613994445391; 225675930 00763000406011; 225675932 00613994445391; 225686835 00613994445391; 225749841 00763000406011; 226111239 00613994445391; 226242273 00763000624798; 226288883 00763000624798; 226335146 00613994445391; 226335147 00763000624798; 226335148 00613994445391; 226366036 00763000624798; 226420635 00763000406011; 226420636 00763000624798; 226517902 00613994445391; 226567491 00763000624798; 226616245 00763000624798; 226734637 00763000624798; 226734639 00763000624798; 226734641 00763000624798; 226734643 00763000624798; 226734645 00763000624798; 226734686 00763000624798; 226756274 00613994445391; 226899371 00763000406011; 226899373 00763000624798; 226899375 00613994445391; 226899378 00613994445391; 226899379 00613994445391; 226899380 00613994445391; 227007688 00763000406011; 227136780 00763000624798; 227188109 00763000624798; 227307931 00763000406011. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
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      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1165-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1165-2024&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1165-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1165-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class I",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1165-2024&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1165-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1165-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1165-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medtronic Neurosurgery",
            "Status": "recorded"
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        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for catheter disconnection   from the patient line stopcock connectors.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-01-22",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Number/GTIN: 221343119 00613994445391; 221612695 00613994445391; 221873429 00613994445391; 221873431 00763000406011; 222082062 00613994445391; 222480771 00763000406011; 222480772 00763000406011; 223565026 00763000624798; 223580361 00763000624798; 223580378 00763000624798; 223618474 00763000624798; 223621056 00763000624798; 223659561 00763000624798; 223907224 00613994445391; 223907225 00613994445391; 223956150 00613994445391; 223999042 00613994445391; 223999043 00613994445391; 224032609 00613994445391; 224128508 00763000406011; 224387126 00763000406011; 224852795 00613994445391; 224852796 00613994445391; 224878536 00613994445391; 224949834 00613994445391; 224949835 00613994445391; 224990657 00763000624798; 224990660 00613994445391; 224990846 00613994445391; 224990847 00763000624798; 224990889 00763000624798; 225198821 00613994445391; 225500036 00613994445391; 225500037 00613994445391; 225675930 00763000406011; 225675932 00613994445391; 225686835 00613994445391; 225749841 00763000406011; 226111239 00613994445391; 226242273 00763000624798; 226288883 00763000624798; 226335146 00613994445391; 226335147 00763000624798; 226335148 00613994445391; 226366036 00763000624798; 226420635 00763000406011; 226420636 00763000624798; 226517902 00613994445391; 226567491 00763000624798; 226616245 00763000624798; 226734637 00763000624798; 226734639 00763000624798; 226734641 00763000624798; 226734643 00763000624798; 226734645 00763000624798; 226734686 00763000624798; 226756274 00613994445391; 226899371 00763000406011; 226899373 00763000624798; 226899375 00613994445391; 226899378 00613994445391; 226899379 00613994445391; 226899380 00613994445391; 227007688 00763000406011; 227136780 00763000624798; 227188109 00763000624798; 227307931 00763000406011",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE,\tFL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and  OUS (foreign): Argentina, Australia, Bahrain, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Gabon, Germany, Ghana, Greece, Hong Kong, Iceland, Iran, Islamic Republic Of\tIreland, Italy, Kazakhstan, Kuwait, Latvia, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, \tRomania, \tRussian Federation, Saudi Arabia,\tSingapore, South Africa, Spain, Sweden,\tSwitzerland, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}