{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1797-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medtronic Left Heart Vent Catheters:    a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012,   b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008,   c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001,   d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113,   e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016,   f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002,   g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220,   h) DLP¿ Pericardial Sump   38.1 cm (15 in), Model Number 12010,",
  "description": "FDA recall Z-1797-2024 — Medtronic Perfusion Systems is recalling Medtronic Left Heart Vent Catheters:    a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012,   b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008,   c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001,   d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113,   e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016,   f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002,   g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220,   h) DLP¿ Pericardial Sump   38.1 cm (15 in), Model Number 12010, (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1797-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medtronic Left Heart Vent Catheters:    a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012,   b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008,   c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001,   d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113,   e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016,   f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002,   g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220,   h) DLP¿ Pericardial Sump   38.1 cm (15 in), Model Number 12010,",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medtronic Perfusion Systems"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1797-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1797-2024: Medtronic Perfusion Systems is recalling Medtronic Left Heart Vent Catheters:    a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012,   b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008,   c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001,   d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113,   e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016,   f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002,   g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220,   h) DLP¿ Pericardial Sump   38.1 cm (15 in), Model Number 12010,",
      "text": "The FDA logged enforcement record Z-1797-2024: Medtronic Perfusion Systems is voluntarily recalling Medtronic Left Heart Vent Catheters:    a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012,   b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008,   c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001,   d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113,   e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016,   f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002,   g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220,   h) DLP¿ Pericardial Sump   38.1 cm (15 in), Model Number 12010, — reason: Potential for unsealed sterile packing.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-19. Affected lots/codes: a) Model Number 12012, GTIN 20613994619246, Lot Numbers:  2023050080, 202306C144;   b) Model Number 12008, GTIN 00643169880665, Lot Numbers:  2023040819;   b) Model Number 12008, GTIN 00673978176307, Lot Numbers:  2023040819, 2023040820;   b) Model Number 12008, GTIN 20643169880669, Lot Numbers:  2023040819, 2023040820, 202307C103;   c) Model Number 12001, GTIN 00643169878686, Lot Numbers:  2023040810;   c) Model Number 12001, GTIN 20643169878680, Lot Numbers:  2023040810, 2023040811, 202306C141;   d) Model Number 12113, GTIN 20643169881338, Lot Numbers:  2023090675;   e) Model Number 12016, GTIN 20613994540434, Lot Numbers:  2023050083, 202305C093;   f) Model Number 12002, GTIN 20613994540465, Lot Numbers:  2023041178, 202305C079;   g) Model Number 12220, GTIN 00613994540355, Lot Numbers:  2023041202, 2023050095;   g) Model Number 12220, GTIN 20613994540359, Lot Numbers:  2023041202, 2023050095, 202305C096, 202306C159;   h) Model Number 12010, GTIN 00673978176321, Lot Numbers:  2023041180, 2023041182, 2023041183, 2023041188, 2023041189, 2023050075;   h) Model Number 12010, GTIN 20613994619215, Lot Numbers:  2023041180, 2023041181, 2023041182, 2023041183, 2023041184, 2023041188, 2023041189, 2023050075, 202305C086, 202305C087. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "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-1797-2024&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-1797-2024&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-1797-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1797-2024 as Class II",
      "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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "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-1797-2024&lang=eng",
        "value": "Class II",
        "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-1797-2024&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-1797-2024/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
      },
      "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": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1797-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1797-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medtronic Perfusion Systems",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for unsealed sterile packing.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-03-19",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) Model Number 12012, GTIN 20613994619246, Lot Numbers:  2023050080, 202306C144;   b) Model Number 12008, GTIN 00643169880665, Lot Numbers:  2023040819;   b) Model Number 12008, GTIN 00673978176307, Lot Numbers:  2023040819, 2023040820;   b) Model Number 12008, GTIN 20643169880669, Lot Numbers:  2023040819, 2023040820, 202307C103;   c) Model Number 12001, GTIN 00643169878686, Lot Numbers:  2023040810;   c) Model Number 12001, GTIN 20643169878680, Lot Numbers:  2023040810, 2023040811, 202306C141;   d) Model Number 12113, GTIN 20643169881338, Lot Numbers:  2023090675;   e) Model Number 12016, GTIN 20613994540434, Lot Numbers:  2023050083, 202305C093;   f) Model Number 12002, GTIN 20613994540465, Lot Numbers:  2023041178, 202305C079;   g) Model Number 12220, GTIN 00613994540355, Lot Numbers:  2023041202, 2023050095;   g) Model Number 12220, GTIN 20613994540359, Lot Numbers:  2023041202, 2023050095, 202305C096, 202306C159;   h) Model Number 12010, GTIN 00673978176321, Lot Numbers:  2023041180, 2023041182, 2023041183, 2023041188, 2023041189, 2023050075;   h) Model Number 12010, GTIN 20613994619215, Lot Numbers:  2023041180, 2023041181, 2023041182, 2023041183, 2023041184, 2023041188, 2023041189, 2023050075, 202305C086, 202305C087",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}