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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1686-2025.jsonld",
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  "name": "IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100.  The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.",
  "description": "FDA recall Z-1686-2025 — Boston Scientific Corporation is recalling IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100.  The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. (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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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1686-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100.  The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.",
    "manufacturer": {
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      "name": "Boston Scientific Corporation"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1686-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1686-2025: Boston Scientific Corporation is recalling IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100.  The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.",
      "text": "The FDA logged enforcement record Z-1686-2025: Boston Scientific Corporation is voluntarily recalling IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100.  The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. — reason: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-24. Affected lots/codes: GTIN 00191506032678, Batch Numbers:  33744602, 33744603, 33744604, 33744605, 33931901, 33937786, 33937787, 33942987, 33942988, 33942989, 33950417, 33950418, 33996423, 33996424, 33996428, 34038291, 34038292, 34038307, 34117281, 34128141, 34128142, 34151877, 34151878, 34204928, 34204929, 34256930, 34256931, 34256932, 34295233.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-1686-2025&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-1686-2025&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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1686-2025/fda-classification",
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      "name": "FDA classified recall Z-1686-2025 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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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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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-1686-2025&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-1686-2025/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",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "groundingType": "Interpretation",
        "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-1686-2025",
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            "Value": "Z-1686-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "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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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.",
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          "item": {
            "Field": "Initiated",
            "Value": "2025-03-24",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "GTIN 00191506032678, Batch Numbers:  33744602, 33744603, 33744604, 33744605, 33931901, 33937786, 33937787, 33942987, 33942988, 33942989, 33950417, 33950418, 33996423, 33996424, 33996428, 34038291, 34038292, 34038307, 34117281, 34128141, 34128142, 34151877, 34151878, 34204928, 34204929, 34256930, 34256931, 34256932, 34295233.",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide",
            "Status": "recorded"
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