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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2104-2025.jsonld",
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  "name": "VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.    Product ID VXW0002    Device approved and commercialized in Japan only.",
  "description": "FDA recall Z-2104-2025 — Boston Scientific Corporation is recalling VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.    Product ID VXW0002    Device approved and commercialized in Japan only. (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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    "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-2104-2025&lang=eng",
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    "name": "VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.    Product ID VXW0002    Device approved and commercialized in Japan only.",
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      "name": "FDA recall Z-2104-2025: Boston Scientific Corporation is recalling VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.    Product ID VXW0002    Device approved and commercialized in Japan only.",
      "text": "The FDA logged enforcement record Z-2104-2025: Boston Scientific Corporation is voluntarily recalling VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.    Product ID VXW0002    Device approved and commercialized in Japan only. — 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: UDI-DI 00685447006121 Lot 35935598. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "supported": true,
        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2104-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2104-2025&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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2104-2025/fda-classification",
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      "name": "FDA classified recall Z-2104-2025 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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      "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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      "@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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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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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-2104-2025",
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            "Status": "recorded"
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            "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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            "Value": "2025-06-10",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.",
            "Status": "recorded"
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