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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2105-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "VersaCross Transseptal Sheath Kit (VXS)  Product Description/IDs  VXS0201  VXS 63CM/45DEG/D0 SHEATH    VXS2112  VERSACROSS SHEATH (63CM 45DEG D0)-J    Used for the percutaneous introduction of various types of  cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal  perforation / puncture.",
  "description": "FDA recall Z-2105-2025 — Boston Scientific Corporation is recalling VersaCross Transseptal Sheath Kit (VXS)  Product Description/IDs  VXS0201  VXS 63CM/45DEG/D0 SHEATH    VXS2112  VERSACROSS SHEATH (63CM 45DEG D0)-J    Used for the percutaneous introduction of various types of  cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal  perforation / puncture. (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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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2105-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "VersaCross Transseptal Sheath Kit (VXS)  Product Description/IDs  VXS0201  VXS 63CM/45DEG/D0 SHEATH    VXS2112  VERSACROSS SHEATH (63CM 45DEG D0)-J    Used for the percutaneous introduction of various types of  cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal  perforation / puncture.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Boston Scientific Corporation"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2105-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2105-2025: Boston Scientific Corporation is recalling VersaCross Transseptal Sheath Kit (VXS)  Product Description/IDs  VXS0201  VXS 63CM/45DEG/D0 SHEATH    VXS2112  VERSACROSS SHEATH (63CM 45DEG D0)-J    Used for the percutaneous introduction of various types of  cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal  perforation / puncture.",
      "text": "The FDA logged enforcement record Z-2105-2025: Boston Scientific Corporation is voluntarily recalling VersaCross Transseptal Sheath Kit (VXS)  Product Description/IDs  VXS0201  VXS 63CM/45DEG/D0 SHEATH    VXS2112  VERSACROSS SHEATH (63CM 45DEG D0)-J    Used for the percutaneous introduction of various types of  cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal  perforation / puncture. — reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-06-10. Affected lots/codes: VXS0201 UDI-DI 00685447020301 Lot 35800622;  VXS2112 UDI-DI 00685447019251 Lot 35892045. 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-2105-2025&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-2105-2025&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-2105-2025 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.",
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        "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-2105-2025&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-2105-2025/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",
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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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      "name": "FDA recall details — Z-2105-2025",
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            "Value": "Z-2105-2025",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
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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.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Boston Scientific Corporation",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-06-10",
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            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.",
            "Status": "recorded"
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