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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0904-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medtronic NanoCross Elite PTA catheter,   REF numbers amd sizes:    1) AB14W050020090, Size:   5MM X 20MM X 90CM;   2) AB14W050020150, Size:   5MM X 20MM X 150CM;   3) AB14W050040090, Size:   5MM X 40MM X 90CM;   4) AB14W050040150, Size:   5MM X 40MM X 150CM;   5) AB14W050060150, Size:   5MM X 60MM X 150CM;   6) AB14W050080090, Size:   5MM X 80MM X 90CM;   7) AB14W050080150, Size:   5MM X 80MM X 150CM;   8) AB14W050100150, Size:   5MM X 100MM X 150CM;   9) AB14W050120150, Size:   5MM X 120MM X 150CM;   10) AB14W050150150, Size:   5MM X 150MM X 150CM;   11) AB14W050200090, Size:   5MM X 200MM X 90CM;   12) AB14W050200150, Size:   5MM X 200MM X 150CM;   13) AB14W060040090, Size:   6MM X 40MM X 90CM;   14) AB14W060040150, Size:   6MM X 40MM X 150CM;   15) AB14W060060150, Size:   6MM X 60MM X 150CM;   16) AB14W060080150, Size:   6MM X 80MM X 150CM;   17) AB14W060100150, Size:   6MM X 100MM X 150CM;   18) AB14W060120150, Size:   6MM X 120MM X 150CM;   19) AB14W060150150, Size:   6MM X 150MM X 150CM;   20) AB14W060200150, Size:   6MM X 200MM X 150CM;   Balloon Dilatation Catheter",
  "description": "FDA recall Z-0904-2025 — ev3 Inc is recalling Medtronic NanoCross Elite PTA catheter,   REF numbers amd sizes:    1) AB14W050020090, Size:   5MM X 20MM X 90CM;   2) AB14W050020150, Size:   5MM X 20MM X 150CM;   3) AB14W050040090, Size:   5MM X 40MM X 90CM;   4) AB14W050040150, Size:   5MM X 40MM X 150CM;   5) AB14W050060150, Size:   5MM X 60MM X 150CM;   6) AB14W050080090, Size:   5MM X 80MM X 90CM;   7) AB14W050080150, Size:   5MM X 80MM X 150CM;   8) AB14W050100150, Size:   5MM X 100MM X 150CM;   9) AB14W050120150, Size:   5MM X 120MM X 150CM;   10) AB14W050150150, Size:   5MM X 150MM X 150CM;   11) AB14W050200090, Size:   5MM X 200MM X 90CM;   12) AB14W050200150, Size:   5MM X 200MM X 150CM;   13) AB14W060040090, Size:   6MM X 40MM X 90CM;   14) AB14W060040150, Size:   6MM X 40MM X 150CM;   15) AB14W060060150, Size:   6MM X 60MM X 150CM;   16) AB14W060080150, Size:   6MM X 80MM X 150CM;   17) AB14W060100150, Size:   6MM X 100MM X 150CM;   18) AB14W060120150, Size:   6MM X 120MM X 150CM;   19) AB14W060150150, Size:   6MM X 150MM X 150CM;   20) AB14W060200150, Size:   6MM X 200MM X 150CM;   Balloon Dilatation Catheter (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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      "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-0904-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medtronic NanoCross Elite PTA catheter,   REF numbers amd sizes:    1) AB14W050020090, Size:   5MM X 20MM X 90CM;   2) AB14W050020150, Size:   5MM X 20MM X 150CM;   3) AB14W050040090, Size:   5MM X 40MM X 90CM;   4) AB14W050040150, Size:   5MM X 40MM X 150CM;   5) AB14W050060150, Size:   5MM X 60MM X 150CM;   6) AB14W050080090, Size:   5MM X 80MM X 90CM;   7) AB14W050080150, Size:   5MM X 80MM X 150CM;   8) AB14W050100150, Size:   5MM X 100MM X 150CM;   9) AB14W050120150, Size:   5MM X 120MM X 150CM;   10) AB14W050150150, Size:   5MM X 150MM X 150CM;   11) AB14W050200090, Size:   5MM X 200MM X 90CM;   12) AB14W050200150, Size:   5MM X 200MM X 150CM;   13) AB14W060040090, Size:   6MM X 40MM X 90CM;   14) AB14W060040150, Size:   6MM X 40MM X 150CM;   15) AB14W060060150, Size:   6MM X 60MM X 150CM;   16) AB14W060080150, Size:   6MM X 80MM X 150CM;   17) AB14W060100150, Size:   6MM X 100MM X 150CM;   18) AB14W060120150, Size:   6MM X 120MM X 150CM;   19) AB14W060150150, Size:   6MM X 150MM X 150CM;   20) AB14W060200150, Size:   6MM X 200MM X 150CM;   Balloon Dilatation Catheter",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "ev3 Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0904-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0904-2025: ev3 Inc is recalling Medtronic NanoCross Elite PTA catheter,   REF numbers amd sizes:    1) AB14W050020090, Size:   5MM X 20MM X 90CM;   2) AB14W050020150, Size:   5MM X 20MM X 150CM;   3) AB14W050040090, Size:   5MM X 40MM X 90CM;   4) AB14W050040150, Size:   5MM X 40MM X 150CM;   5) AB14W050060150, Size:   5MM X 60MM X 150CM;   6) AB14W050080090, Size:   5MM X 80MM X 90CM;   7) AB14W050080150, Size:   5MM X 80MM X 150CM;   8) AB14W050100150, Size:   5MM X 100MM X 150CM;   9) AB14W050120150, Size:   5MM X 120MM X 150CM;   10) AB14W050150150, Size:   5MM X 150MM X 150CM;   11) AB14W050200090, Size:   5MM X 200MM X 90CM;   12) AB14W050200150, Size:   5MM X 200MM X 150CM;   13) AB14W060040090, Size:   6MM X 40MM X 90CM;   14) AB14W060040150, Size:   6MM X 40MM X 150CM;   15) AB14W060060150, Size:   6MM X 60MM X 150CM;   16) AB14W060080150, Size:   6MM X 80MM X 150CM;   17) AB14W060100150, Size:   6MM X 100MM X 150CM;   18) AB14W060120150, Size:   6MM X 120MM X 150CM;   19) AB14W060150150, Size:   6MM X 150MM X 150CM;   20) AB14W060200150, Size:   6MM X 200MM X 150CM;   Balloon Dilatation Catheter",
      "text": "The FDA logged enforcement record Z-0904-2025: ev3 Inc is voluntarily recalling Medtronic NanoCross Elite PTA catheter,   REF numbers amd sizes:    1) AB14W050020090, Size:   5MM X 20MM X 90CM;   2) AB14W050020150, Size:   5MM X 20MM X 150CM;   3) AB14W050040090, Size:   5MM X 40MM X 90CM;   4) AB14W050040150, Size:   5MM X 40MM X 150CM;   5) AB14W050060150, Size:   5MM X 60MM X 150CM;   6) AB14W050080090, Size:   5MM X 80MM X 90CM;   7) AB14W050080150, Size:   5MM X 80MM X 150CM;   8) AB14W050100150, Size:   5MM X 100MM X 150CM;   9) AB14W050120150, Size:   5MM X 120MM X 150CM;   10) AB14W050150150, Size:   5MM X 150MM X 150CM;   11) AB14W050200090, Size:   5MM X 200MM X 90CM;   12) AB14W050200150, Size:   5MM X 200MM X 150CM;   13) AB14W060040090, Size:   6MM X 40MM X 90CM;   14) AB14W060040150, Size:   6MM X 40MM X 150CM;   15) AB14W060060150, Size:   6MM X 60MM X 150CM;   16) AB14W060080150, Size:   6MM X 80MM X 150CM;   17) AB14W060100150, Size:   6MM X 100MM X 150CM;   18) AB14W060120150, Size:   6MM X 120MM X 150CM;   19) AB14W060150150, Size:   6MM X 150MM X 150CM;   20) AB14W060200150, Size:   6MM X 200MM X 150CM;   Balloon Dilatation Catheter — reason: There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-10. Affected lots/codes: 1) AB14W050020090, UDI/DI 00763000758035, Serial Numbers:  B738596, B749440, B764968;   2) AB14W050020150, UDI/DI 00763000758042, Serial Numbers:  B761521, B781264, B794814;   3) AB14W050040090, UDI/DI 00763000758059, Serial Numbers:  B740725, B748628;   3) AB14W050040090, UDI/DI 04987742337891, Serial Numbers:  B740725;   4) AB14W050040150, UDI/DI 00763000758066, Serial Numbers:  B748644, B755679, B757663, B760286, B761769, B762343, B775924, B775972, B776408, B792995;   4) AB14W050040150, UDI/DI 04987742337907, Serial Numbers:  B755679;   5) AB14W050060150, UDI/DI 00763000758080, Serial Numbers:  B755683, B761779, B762646, B792990;   6) AB14W050080090, UDI/DI 00763000758097, Serial Numbers:  B797860;   7) AB14W050080150, UDI/DI 00763000758103, Serial Numbers:  B734091, B750081, B755684, B761172, B761754, B762256, B775959, B793874;   8) AB14W050100150, UDI/DI none, Serial Numbers:  B750054, B758860, B761368, B764977, B765527, B769645, B781316, B791878, B805118;   9) AB14W050120150, UDI/DI 00763000758141, Serial Numbers:  B731160, B761782, B762036, B768737, B793229;   10) AB14W050150150, UDI/DI 00763000758165, Serial Numbers:  B727462, B736200, B750625, B758294, B758866, B760303, B762032, B763323, B763333, B763355, B763360, B776072, B792620, B793222;   11) AB14W050200090, UDI/DI 00763000758172, Serial Numbers:  B760301, B789934;   11) AB14W050200090, UDI/DI 04987742337815, Serial Numbers:  B760301;   12) AB14W050200150, UDI/DI 00763000758189, Serial Numbers:  B734116, B740732, B749498, B749509, B754865, B754876, B754889, B754921, B754938, B754944, B762313, B762346, B762623, B762814, B762967, B781392, B791857, B792372, B798527;    13) AB14W060040090, UDI/DI 00763000758219, Serial Numbers:  B730934, B795892;   14) AB14W060040150, UDI/DI 00763000758226, Serial Numbers:  B737344, B748659, B755681, B760297, B761167, B761194, B764136, B764985, B765532, B791881, B793013;   15) AB14W060060150, UDI/DI 00763000758240, Serial Numbers:  B762430, B762853, B791832;   16) AB14W060080150, UDI/DI 00763000758264, Serial Numbers:  B755686, B761181, B762366, B762433, B762921, B793869;   17) AB14W060100150, UDI/DI 00763000758288, Serial Numbers:  B748690, B759617, B762803, B769628, B781383, B792612;   18) AB14W060120150, UDI/DI 00763000758301, Serial Numbers:  B762187, B766265, B789926;   19) AB14W060150150, UDI/DI 00763000758325, Serial Numbers:  B730835, B734241, B757655, B758869, B761533, B776389, B781300, B791875;   20) AB14W060200150, UDI/DI 00763000758349, Serial Numbers:  B726348, B736196, B749504, B750650, B754900, B761765, B762193, B769612, B769616, B769622, B769634, B781989, B792379.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-0904-2025&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-0904-2025&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-0904-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0904-2025 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-0904-2025&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-0904-2025&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-0904-2025/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": [
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      "name": "FDA recall details — Z-0904-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0904-2025",
            "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 II",
            "Status": "determination"
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          "@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": "ev3 Inc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-12-10",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) AB14W050020090, UDI/DI 00763000758035, Serial Numbers:  B738596, B749440, B764968;   2) AB14W050020150, UDI/DI 00763000758042, Serial Numbers:  B761521, B781264, B794814;   3) AB14W050040090, UDI/DI 00763000758059, Serial Numbers:  B740725, B748628;   3) AB14W050040090, UDI/DI 04987742337891, Serial Numbers:  B740725;   4) AB14W050040150, UDI/DI 00763000758066, Serial Numbers:  B748644, B755679, B757663, B760286, B761769, B762343, B775924, B775972, B776408, B792995;   4) AB14W050040150, UDI/DI 04987742337907, Serial Numbers:  B755679;   5) AB14W050060150, UDI/DI 00763000758080, Serial Numbers:  B755683, B761779, B762646, B792990;   6) AB14W050080090, UDI/DI 00763000758097, Serial Numbers:  B797860;   7) AB14W050080150, UDI/DI 00763000758103, Serial Numbers:  B734091, B750081, B755684, B761172, B761754, B762256, B775959, B793874;   8) AB14W050100150, UDI/DI none, Serial Numbers:  B750054, B758860, B761368, B764977, B765527, B769645, B781316, B791878, B805118;   9) AB14W050120150, UDI/DI 00763000758141, Serial Numbers:  B731160, B761782, B762036, B768737, B793229;   10) AB14W050150150, UDI/DI 00763000758165, Serial Numbers:  B727462, B736200, B750625, B758294, B758866, B760303, B762032, B763323, B763333, B763355, B763360, B776072, B792620, B793222;   11) AB14W050200090, UDI/DI 00763000758172, Serial Numbers:  B760301, B789934;   11) AB14W050200090, UDI/DI 04987742337815, Serial Numbers:  B760301;   12) AB14W050200150, UDI/DI 00763000758189, Serial Numbers:  B734116, B740732, B749498, B749509, B754865, B754876, B754889, B754921, B754938, B754944, B762313, B762346, B762623, B762814, B762967, B781392, B791857, B792372, B798527;    13) AB14W060040090, UDI/DI 00763000758219, Serial Numbers:  B730934, B795892;   14) AB14W060040150, UDI/DI 00763000758226, Serial Numbers:  B737344, B748659, B755681, B760297, B761167, B761194, B764136, B764985, B765532, B791881, B793013;   15) AB14W060060150, UDI/DI 00763000758240, Serial Numbers:  B762430, B762853, B791832;   16) AB14W060080150, UDI/DI 00763000758264, Serial Numbers:  B755686, B761181, B762366, B762433, B762921, B793869;   17) AB14W060100150, UDI/DI 00763000758288, Serial Numbers:  B748690, B759617, B762803, B769628, B781383, B792612;   18) AB14W060120150, UDI/DI 00763000758301, Serial Numbers:  B762187, B766265, B789926;   19) AB14W060150150, UDI/DI 00763000758325, Serial Numbers:  B730835, B734241, B757655, B758869, B761533, B776389, B781300, B791875;   20) AB14W060200150, UDI/DI 00763000758349, Serial Numbers:  B726348, B736196, B749504, B750650, B754900, B761765, B762193, B769612, B769616, B769622, B769634, B781989, B792379.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}