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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1042-2026.jsonld",
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  "name": "Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,   1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;   2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;   Catheter, Angioplasty, Peripheral, Transluminal",
  "description": "FDA recall Z-1042-2026 — Boston Scientific Corporation is recalling Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,   1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;   2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;   Catheter, Angioplasty, Peripheral, Transluminal (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,   1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;   2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;   Catheter, Angioplasty, Peripheral, Transluminal",
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      "name": "Boston Scientific Corporation"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1042-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1042-2026: Boston Scientific Corporation is recalling Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,   1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;   2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;   Catheter, Angioplasty, Peripheral, Transluminal",
      "text": "The FDA logged enforcement record Z-1042-2026: Boston Scientific Corporation is voluntarily recalling Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,   1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;   2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;   Catheter, Angioplasty, Peripheral, Transluminal — reason: Boston Scientific is initiating the removal of certain batches of Coyote\" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-03. Affected lots/codes: 1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28;  2) GTIN 08714729796756, Batch Number  37416646, exp. 9-Sept-28. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": 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-1042-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1042-2026&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."
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      "name": "FDA classified recall Z-1042-2026 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.",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1042-2026/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.",
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
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            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Boston Scientific is initiating the removal of certain batches of Coyote\" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.",
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            "Value": "2025-12-03",
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            "Field": "Lot/code info",
            "Value": "1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28;  2) GTIN 08714729796756, Batch Number  37416646, exp. 9-Sept-28",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.",
            "Status": "recorded"
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