{
  "@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-1880-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit,  a) REF IAB-05830-U;  b) REF IAB-05840-U",
  "description": "FDA recall Z-1880-2024 — ARROW INTERNATIONAL Inc. is recalling Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit,  a) REF IAB-05830-U;  b) REF IAB-05840-U (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/",
  "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-1880-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit,  a) REF IAB-05830-U;  b) REF IAB-05840-U",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "ARROW INTERNATIONAL Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1880-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1880-2024: ARROW INTERNATIONAL Inc. is recalling Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit,  a) REF IAB-05830-U;  b) REF IAB-05840-U",
      "text": "The FDA logged enforcement record Z-1880-2024: ARROW INTERNATIONAL Inc. is voluntarily recalling Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit,  a) REF IAB-05830-U;  b) REF IAB-05840-U — reason: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:  -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-29. Affected lots/codes: a) REF IAB-05830-U, UDI:  (01)10801902172850(17)240531(10)18F22F0023, (01)10801902172850(17)240630(10)18F22G0005, (01)10801902172850(17)240630(10)18F22G0010, (01)10801902172850(17)240731(10)18F22H0033, (01)10801902172850(17)250831(10)18F23J0031, (01)10801902172850(17)250930(10)18F23K0036, (01)10801902172850(17)250930(10)18F23K0042, (01)10801902172850(17)251130(10)18F23M0001, (01)10801902182019(17)250430(10)18F23E0032, (01)10801902182019(17)250831(10)18F23J0002, (01)10801902182019(17)250831(10)18F23J0082, (01)10801902182019(17)250930(10)18F23K0025, (01)10801902182019(17)260331(10)18F24C0131;   b) REF IAB-05840-U, UDI:  (01)10801902161922(17)240630(10)18F22G0051, (01)10801902161922(17)241231(10)18F23A0002, (01)10801902161922(17)241231(10)18F23A0021, (01)10801902161922(17)241231(10)18F23A0060, (01)10801902161922(17)250731(10)18F23G0068, (01)10801902161922(17)250930(10)18F23K0012, (01)10801902161922(17)251031(10)18F23K0053, (01)10801902161922(17)251031(10)18F23K0063, (01)10801902161922(17)260131(10)18F24B0051, (01)10801902172874(17)240430(10)18F22E0012, (01)10801902172874(17)240630(10)18F22G0011, (01)10801902172874(17)240630(10)18F22G0016, (01)10801902172874(17)250930(10)18F23K0039, (01)10801902172874(17)251031(10)18F23L0010, (01)10801902172874(17)251031(10)18F23L0031, (01)10801902172874(17)251031(10)18F23L0039, (01)10801902172874(17)251130(10)18F23K0008. 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-1880-2024&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-1880-2024&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-1880-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1880-2024 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
      },
      "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-1880-2024&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-1880-2024&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-1880-2024/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-1880-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1880-2024",
            "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 I",
            "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": "ARROW INTERNATIONAL Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:  -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-04-29",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF IAB-05830-U, UDI:  (01)10801902172850(17)240531(10)18F22F0023, (01)10801902172850(17)240630(10)18F22G0005, (01)10801902172850(17)240630(10)18F22G0010, (01)10801902172850(17)240731(10)18F22H0033, (01)10801902172850(17)250831(10)18F23J0031, (01)10801902172850(17)250930(10)18F23K0036, (01)10801902172850(17)250930(10)18F23K0042, (01)10801902172850(17)251130(10)18F23M0001, (01)10801902182019(17)250430(10)18F23E0032, (01)10801902182019(17)250831(10)18F23J0002, (01)10801902182019(17)250831(10)18F23J0082, (01)10801902182019(17)250930(10)18F23K0025, (01)10801902182019(17)260331(10)18F24C0131;   b) REF IAB-05840-U, UDI:  (01)10801902161922(17)240630(10)18F22G0051, (01)10801902161922(17)241231(10)18F23A0002, (01)10801902161922(17)241231(10)18F23A0021, (01)10801902161922(17)241231(10)18F23A0060, (01)10801902161922(17)250731(10)18F23G0068, (01)10801902161922(17)250930(10)18F23K0012, (01)10801902161922(17)251031(10)18F23K0053, (01)10801902161922(17)251031(10)18F23K0063, (01)10801902161922(17)260131(10)18F24B0051, (01)10801902172874(17)240430(10)18F22E0012, (01)10801902172874(17)240630(10)18F22G0011, (01)10801902172874(17)240630(10)18F22G0016, (01)10801902172874(17)250930(10)18F23K0039, (01)10801902172874(17)251031(10)18F23L0010, (01)10801902172874(17)251031(10)18F23L0031, (01)10801902172874(17)251031(10)18F23L0039, (01)10801902172874(17)251130(10)18F23K0008",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.  US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}