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  "name": "Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a  means to reduce intracranial pressure and CSF volume.",
  "description": "FDA recall Z-1163-2024 — Medtronic Neurosurgery is recalling Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, 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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a  means to reduce intracranial pressure and CSF volume.",
    "manufacturer": {
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      "name": "Medtronic Neurosurgery"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1163-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1163-2024: Medtronic Neurosurgery is recalling Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, 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-1163-2024: Medtronic Neurosurgery is voluntarily recalling Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, 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: 221482529 00763000395971; 221520718 00763000395971; 221648854 00763000395971; 221687765 00763000395971; 221744158 00763000395971; 221744549 00763000395971; 221795479 00613994445377; 221827827 00613994445377; 221827828 00613994445377; 221873427 00763000395971; 221873428 00763000395971; 221915124 00763000395971; 221915125 00763000395971; 221916163 00613994445377; 221916164 00763000395971; 221955230 00763000395971; 221955231 00763000395971; 222015665 00613994445377; 222061755 00613994445377; 222204094 00613994445377; 222345104 00613994445377; 222345105 00613994445377; 222346067 00613994445377; 222393929 00763000395971; 222393930 00763000395971; 222530273 00613994445377; 222543362 00763000395971; 222543363 00763000395971; 222580924 00613994445377; 222970856 00613994445377; 222970857 00613994445377; 222970858 00613994445377; 222999295 00613994445377; 222999296 00613994445377; 223070846 00763000395971; 223130156 00763000395971; 223165960 00763000395971; 223165961 00763000395971; 223165962 00763000395971; 223251949 00763000395971; 223580360 00763000624774; 223620063 00763000624774; 223621055 00763000624774; 223659559 00763000624774; 223659560 00763000624774; 223698571 00763000624774; 223734521 00763000624774; 223734522 00763000624774; 223778509 00763000624774; 223999041 00613994445377; 224032597 00763000624774; 224173197 00763000395971; 224342656 00763000395971; 224387139 00763000395971; 224852792 00763000624774; 224852793 00763000624774; 224852794 00763000624774; 224877792 00763000624774; 224878534 00763000624774; 224878535 00763000624774; 224918537 00763000624774; 224949833 00613994445377; 224990656 00763000624774; 224990658 00613994445377; 224990659 00613994445377; 224990661 00613994445377; 224990664 00763000624774; 224990665 00763000624774; 224990851 00763000624774; 224990869 00763000624774; 224990887 00763000624774; 224990888 00763000624774; 225035347 00763000624774; 225234319 00763000395971; 225279761 00763000395971; 225422433 00763000624774; 225468089 00763000395971; 225500028 00763000395971; 225558568 00613994445377; 225587871 00763000395971; 225587872 00763000395971; 225587873 00763000624774; 225587874 00763000624774; 225749839 00763000395971; 225749840 00763000624774; 226111272 00763000395971; 226242266 00763000624774; 226242267 00763000624774; 226242268 00763000624774; 226242269 00763000624774; 226288881 00763000624774; 226288882 00763000624774; 226335063 00763000624774; 226335064 00763000624774; 226335065 00763000624774; 226366037 00613994445377; 226420630 00613994445377; 226420631 00763000395971; 226420632 00763000624774; 226490978 00613994445377; 226490979 00613994445377; 226517897 00763000624774; 226517898 00763000624774; 226567488 00763000624774; 226567489 00763000624774; 226567490 00763000624774; 226567492 00763000624774; 226616244 00763000624774; 226616246 00763000395971; 226756270 00763000395971; 226756271 00763000624774; 226756272 00763000624774; 226810274 00763000624774; 226899370 00763000395971; 226899372 00763000624774; 226951461 00763000395971; 226951462 00763000395971; 226951463 00763000624774; 226951464 00763000624774; 227006497 00763000624774; 227007687 00763000624774; 227136770 00763000624774; 227188107 00763000624774; 227289116 00763000395971; 227289117 00763000395971; 227307929 00763000624774; 227387373 00763000624774;. A RECORDED FDA enforcement action (occurred=true).",
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      "grounding": {
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1163-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1163-2024&lang=eng"
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      "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-1163-2024/fda-classification",
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      "name": "FDA classified recall Z-1163-2024 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,
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1163-2024&lang=eng",
        "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-1163-2024&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-1163-2024/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",
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      "epistemicStatus": {
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        "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."
    }
  ],
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      "name": "FDA recall details — Z-1163-2024",
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            "Value": "Z-1163-2024",
            "Status": "recorded"
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            "Value": "Devices",
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            "Field": "Classification",
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
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            "Status": "recorded"
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            "Field": "Reason",
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            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-01-22",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Number/GTIN: 221482529 00763000395971; 221520718 00763000395971; 221648854 00763000395971; 221687765 00763000395971; 221744158 00763000395971; 221744549 00763000395971; 221795479 00613994445377; 221827827 00613994445377; 221827828 00613994445377; 221873427 00763000395971; 221873428 00763000395971; 221915124 00763000395971; 221915125 00763000395971; 221916163 00613994445377; 221916164 00763000395971; 221955230 00763000395971; 221955231 00763000395971; 222015665 00613994445377; 222061755 00613994445377; 222204094 00613994445377; 222345104 00613994445377; 222345105 00613994445377; 222346067 00613994445377; 222393929 00763000395971; 222393930 00763000395971; 222530273 00613994445377; 222543362 00763000395971; 222543363 00763000395971; 222580924 00613994445377; 222970856 00613994445377; 222970857 00613994445377; 222970858 00613994445377; 222999295 00613994445377; 222999296 00613994445377; 223070846 00763000395971; 223130156 00763000395971; 223165960 00763000395971; 223165961 00763000395971; 223165962 00763000395971; 223251949 00763000395971; 223580360 00763000624774; 223620063 00763000624774; 223621055 00763000624774; 223659559 00763000624774; 223659560 00763000624774; 223698571 00763000624774; 223734521 00763000624774; 223734522 00763000624774; 223778509 00763000624774; 223999041 00613994445377; 224032597 00763000624774; 224173197 00763000395971; 224342656 00763000395971; 224387139 00763000395971; 224852792 00763000624774; 224852793 00763000624774; 224852794 00763000624774; 224877792 00763000624774; 224878534 00763000624774; 224878535 00763000624774; 224918537 00763000624774; 224949833 00613994445377; 224990656 00763000624774; 224990658 00613994445377; 224990659 00613994445377; 224990661 00613994445377; 224990664 00763000624774; 224990665 00763000624774; 224990851 00763000624774; 224990869 00763000624774; 224990887 00763000624774; 224990888 00763000624774; 225035347 00763000624774; 225234319 00763000395971; 225279761 00763000395971; 225422433 00763000624774; 225468089 00763000395971; 225500028 00763000395971; 225558568 00613994445377; 225587871 00763000395971; 225587872 00763000395971; 225587873 00763000624774; 225587874 00763000624774; 225749839 00763000395971; 225749840 00763000624774; 226111272 00763000395971; 226242266 00763000624774; 226242267 00763000624774; 226242268 00763000624774; 226242269 00763000624774; 226288881 00763000624774; 226288882 00763000624774; 226335063 00763000624774; 226335064 00763000624774; 226335065 00763000624774; 226366037 00613994445377; 226420630 00613994445377; 226420631 00763000395971; 226420632 00763000624774; 226490978 00613994445377; 226490979 00613994445377; 226517897 00763000624774; 226517898 00763000624774; 226567488 00763000624774; 226567489 00763000624774; 226567490 00763000624774; 226567492 00763000624774; 226616244 00763000624774; 226616246 00763000395971; 226756270 00763000395971; 226756271 00763000624774; 226756272 00763000624774; 226810274 00763000624774; 226899370 00763000395971; 226899372 00763000624774; 226951461 00763000395971; 226951462 00763000395971; 226951463 00763000624774; 226951464 00763000624774; 227006497 00763000624774; 227007687 00763000624774; 227136770 00763000624774; 227188107 00763000624774; 227289116 00763000395971; 227289117 00763000395971; 227307929 00763000624774; 227387373 00763000624774;",
            "Status": "recorded"
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          "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.",
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}