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  "description": "FDA recall Z-2103-2025 — Boston Scientific Corporation is recalling VersaCross Access Solution (VXSK),  Product Description and ID:    VXSK (180J RF WIRE 63CM/45DEG/D0)  VXSK0101  VXSK (180J RF WIRE 63CM/45DEG/D1)  VXSK0102  VXSK (180J RF WIRE 63CM/55DEG/D0)  VXSK0103  VXSK (180P RF WIRE 63CM/45DEG/D0)  VXSK0121  VXSK (180P RF WIRE 63CM/45DEG/D1)  VXSK0122  VXSK (180P RF WIRE 63CM/55DEG/D0)  VXSK0123  VXSK (180P RF WIRE 63CM/55DEG/D1)  VXSK0124  VXSK (180P RF WIRE 63CM/90DEG/D0)  VXSK0125  VXSK (230J RF WIRE 63CM/45DEG/D0)  VXSK0111  VXSK (230J RF WIRE 63CM/45DEG/D1)  VXSK0112  VXSK (230P RF WIRE 63CM/45DEG/D0)  VXSK0131  VXSK (230P RF WIRE 63CM/45DEG/D1)  VXSK0132  VXSK (230P RF WIRE 63CM/55DEG/D0)  VXSK0133  VXSK (230P RF WIRE 63CM/55DEG/D1)  VXSK0134  VXSK (230P RF WIRE 81CM/45DEG/D0)  VXSK0137  VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0021  VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0022  VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0024  VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH  VXSK0025  VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0031  VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0032  VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0034 (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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    "@type": "schema:MedicalDevice",
    "name": "VersaCross Access Solution (VXSK),  Product Description and ID:    VXSK (180J RF WIRE 63CM/45DEG/D0)  VXSK0101  VXSK (180J RF WIRE 63CM/45DEG/D1)  VXSK0102  VXSK (180J RF WIRE 63CM/55DEG/D0)  VXSK0103  VXSK (180P RF WIRE 63CM/45DEG/D0)  VXSK0121  VXSK (180P RF WIRE 63CM/45DEG/D1)  VXSK0122  VXSK (180P RF WIRE 63CM/55DEG/D0)  VXSK0123  VXSK (180P RF WIRE 63CM/55DEG/D1)  VXSK0124  VXSK (180P RF WIRE 63CM/90DEG/D0)  VXSK0125  VXSK (230J RF WIRE 63CM/45DEG/D0)  VXSK0111  VXSK (230J RF WIRE 63CM/45DEG/D1)  VXSK0112  VXSK (230P RF WIRE 63CM/45DEG/D0)  VXSK0131  VXSK (230P RF WIRE 63CM/45DEG/D1)  VXSK0132  VXSK (230P RF WIRE 63CM/55DEG/D0)  VXSK0133  VXSK (230P RF WIRE 63CM/55DEG/D1)  VXSK0134  VXSK (230P RF WIRE 81CM/45DEG/D0)  VXSK0137  VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0021  VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0022  VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0024  VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH  VXSK0025  VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0031  VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0032  VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0034",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2103-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2103-2025: Boston Scientific Corporation is recalling VersaCross Access Solution (VXSK),  Product Description and ID:    VXSK (180J RF WIRE 63CM/45DEG/D0)  VXSK0101  VXSK (180J RF WIRE 63CM/45DEG/D1)  VXSK0102  VXSK (180J RF WIRE 63CM/55DEG/D0)  VXSK0103  VXSK (180P RF WIRE 63CM/45DEG/D0)  VXSK0121  VXSK (180P RF WIRE 63CM/45DEG/D1)  VXSK0122  VXSK (180P RF WIRE 63CM/55DEG/D0)  VXSK0123  VXSK (180P RF WIRE 63CM/55DEG/D1)  VXSK0124  VXSK (180P RF WIRE 63CM/90DEG/D0)  VXSK0125  VXSK (230J RF WIRE 63CM/45DEG/D0)  VXSK0111  VXSK (230J RF WIRE 63CM/45DEG/D1)  VXSK0112  VXSK (230P RF WIRE 63CM/45DEG/D0)  VXSK0131  VXSK (230P RF WIRE 63CM/45DEG/D1)  VXSK0132  VXSK (230P RF WIRE 63CM/55DEG/D0)  VXSK0133  VXSK (230P RF WIRE 63CM/55DEG/D1)  VXSK0134  VXSK (230P RF WIRE 81CM/45DEG/D0)  VXSK0137  VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0021  VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0022  VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0024  VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH  VXSK0025  VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0031  VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0032  VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0034",
      "text": "The FDA logged enforcement record Z-2103-2025: Boston Scientific Corporation is voluntarily recalling VersaCross Access Solution (VXSK),  Product Description and ID:    VXSK (180J RF WIRE 63CM/45DEG/D0)  VXSK0101  VXSK (180J RF WIRE 63CM/45DEG/D1)  VXSK0102  VXSK (180J RF WIRE 63CM/55DEG/D0)  VXSK0103  VXSK (180P RF WIRE 63CM/45DEG/D0)  VXSK0121  VXSK (180P RF WIRE 63CM/45DEG/D1)  VXSK0122  VXSK (180P RF WIRE 63CM/55DEG/D0)  VXSK0123  VXSK (180P RF WIRE 63CM/55DEG/D1)  VXSK0124  VXSK (180P RF WIRE 63CM/90DEG/D0)  VXSK0125  VXSK (230J RF WIRE 63CM/45DEG/D0)  VXSK0111  VXSK (230J RF WIRE 63CM/45DEG/D1)  VXSK0112  VXSK (230P RF WIRE 63CM/45DEG/D0)  VXSK0131  VXSK (230P RF WIRE 63CM/45DEG/D1)  VXSK0132  VXSK (230P RF WIRE 63CM/55DEG/D0)  VXSK0133  VXSK (230P RF WIRE 63CM/55DEG/D1)  VXSK0134  VXSK (230P RF WIRE 81CM/45DEG/D0)  VXSK0137  VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0021  VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0022  VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0024  VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH  VXSK0025  VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0031  VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0032  VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0034 — 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: Product ID/UDI-DI/Batch Numbers:  VXSK0021 UDI-DI 00685447011729 Lots 35590858 35607785 35627540;  VXSK0022 UDI-DI 00685447011736 Lots 35487923 35544014 35552652 35566071 35595443 35604160 35616857  VXSK0024 UDI-DI 00685447011750 Lot 35576278;  VXSK0025 UDI-DI 00685447011767 Lot 35582041; VXSK0031 UDI-DI 00685447011828 Lots 35499536 35627156;  VXSK0032 UDI-DI 00685447011835 Lots 35508294 35518904 35563958 35582043 35635451;  VXSK0034 UDI-DI 00685447011859 Lots 35573519 35593310;  VXSK0101 UDI-DI 00685447019749 Lot 35893570;  VXSK0102 UDI-DI 00685447019756 Lot 35720571;  VXSK0103 UDI-DI 00685447019763 Lot 36042383;  VXSK0111 UDI-DI 00685447019794 Lot 35944186;  VXSK0112 UDI-DI 00685447019800 Lot 36061050;  VXSK0121 UDI-DI 00685447019817 Lots 35745702 35787463;  VXSK0122 UDI-DI 00685447019824 Lots 35699501 35720572 35768613 35780309 35790937 35830237 35833400;  VXSK0123 UDI-DI 00685447019831 Lot 35843757;  VXSK0124 UDI-DI 00685447019848 Lots 35697863 35883199;  VXSK0125 UDI-DI 00685447019855 Lot 35859706;  VXSK0131 UDI-DI 00685447019862 Lots 35729751 35807530 35900608;  VXSK0132 UDI-DI 00685447019879 Lots 35695371 35729750 35807531 35910367 35955008;  VXSK0133 UDI-DI 00685447019886 Lot 35839894;  VXSK0134 UDI-DI 00685447019893 Lot 35666909;  VXSK0137 UDI-DI 00685447019909 Lot 35985522. A RECORDED FDA enforcement action (occurred=true).",
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        "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-2103-2025&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-2103-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2103-2025 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": {
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        "adjudged": true,
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        "value": "Class II",
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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-2103-2025/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
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      "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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          "item": {
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            "Value": "Class II",
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          "item": {
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
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            "Field": "Recalling firm",
            "Value": "Boston Scientific Corporation",
            "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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            "Field": "Initiated",
            "Value": "2025-06-10",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Product ID/UDI-DI/Batch Numbers:  VXSK0021 UDI-DI 00685447011729 Lots 35590858 35607785 35627540;  VXSK0022 UDI-DI 00685447011736 Lots 35487923 35544014 35552652 35566071 35595443 35604160 35616857  VXSK0024 UDI-DI 00685447011750 Lot 35576278;  VXSK0025 UDI-DI 00685447011767 Lot 35582041; VXSK0031 UDI-DI 00685447011828 Lots 35499536 35627156;  VXSK0032 UDI-DI 00685447011835 Lots 35508294 35518904 35563958 35582043 35635451;  VXSK0034 UDI-DI 00685447011859 Lots 35573519 35593310;  VXSK0101 UDI-DI 00685447019749 Lot 35893570;  VXSK0102 UDI-DI 00685447019756 Lot 35720571;  VXSK0103 UDI-DI 00685447019763 Lot 36042383;  VXSK0111 UDI-DI 00685447019794 Lot 35944186;  VXSK0112 UDI-DI 00685447019800 Lot 36061050;  VXSK0121 UDI-DI 00685447019817 Lots 35745702 35787463;  VXSK0122 UDI-DI 00685447019824 Lots 35699501 35720572 35768613 35780309 35790937 35830237 35833400;  VXSK0123 UDI-DI 00685447019831 Lot 35843757;  VXSK0124 UDI-DI 00685447019848 Lots 35697863 35883199;  VXSK0125 UDI-DI 00685447019855 Lot 35859706;  VXSK0131 UDI-DI 00685447019862 Lots 35729751 35807530 35900608;  VXSK0132 UDI-DI 00685447019879 Lots 35695371 35729750 35807531 35910367 35955008;  VXSK0133 UDI-DI 00685447019886 Lot 35839894;  VXSK0134 UDI-DI 00685447019893 Lot 35666909;  VXSK0137 UDI-DI 00685447019909 Lot 35985522",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}