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  "name": "Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter",
  "description": "FDA recall Z-0011-2024 — Boston Scientific Corporation is recalling Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter (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": "Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0011-2024/enforcement-record",
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      "name": "FDA recall Z-0011-2024: Boston Scientific Corporation is recalling Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter",
      "text": "The FDA logged enforcement record Z-0011-2024: Boston Scientific Corporation is voluntarily recalling Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter — reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-07-27. Affected lots/codes: GTIN 08714729202486, Lot/Batch Numbers:  25651714, 25651716, 26034835, 26034836, 26034839, 25651712, 25651713, 25651715, 25651717, 25651718, 25651719, 26034834, 26034837, 26034838, 26059640, 26059641, 26138712, 26338710, 26338711, 26338712, 26338713, 26338714, 26338715, 26599628, 26599629, 26599632, 26599633, 26745651, 26745652, 26745653, 26745654, 26745655, 26745656, 26891494, 26891499, 26891761, 26891762, 26891763, 26891764, 26891766, 26891767, 27081946, 27162090, 27162091, 27162092, 27184893, 27184895, 27192450, 27192451, 27347761, 27386636, 27516584, 27568838, 27568839, 27654466, 27661667, 27669282, 27728491, 27894535, 27943983, 28320869, 28320870, 28320871, 28320872, 28384638, 28384639, 28384660, 26599625, 28471411, 28502668, 28502669, 26599626, 28676785, 28676786, 28676787, 28676788, 29308869, 26599627, 29308874, 26599630, 26599631, 26745650, 26891492, 26891493, 26891495, 26891760, 26891765, 27081947, 27367346, 27367347, 27661666, 27669283, 27735227, 27735228, 27894534, 28471410, 28502670, 29308872. A RECORDED FDA enforcement action (occurred=true).",
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      "epistemicStatus": {
        "occurred": true,
        "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-0011-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-0011-2024 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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      "reviewStatus": "current",
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0011-2024/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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        "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": "Recall number",
            "Value": "Z-0011-2024",
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            "Value": "Devices",
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            "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": "Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.",
            "Status": "recorded"
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            "Value": "2023-07-27",
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            "Field": "Lot/code info",
            "Value": "GTIN 08714729202486, Lot/Batch Numbers:  25651714, 25651716, 26034835, 26034836, 26034839, 25651712, 25651713, 25651715, 25651717, 25651718, 25651719, 26034834, 26034837, 26034838, 26059640, 26059641, 26138712, 26338710, 26338711, 26338712, 26338713, 26338714, 26338715, 26599628, 26599629, 26599632, 26599633, 26745651, 26745652, 26745653, 26745654, 26745655, 26745656, 26891494, 26891499, 26891761, 26891762, 26891763, 26891764, 26891766, 26891767, 27081946, 27162090, 27162091, 27162092, 27184893, 27184895, 27192450, 27192451, 27347761, 27386636, 27516584, 27568838, 27568839, 27654466, 27661667, 27669282, 27728491, 27894535, 27943983, 28320869, 28320870, 28320871, 28320872, 28384638, 28384639, 28384660, 26599625, 28471411, 28502668, 28502669, 26599626, 28676785, 28676786, 28676787, 28676788, 29308869, 26599627, 29308874, 26599630, 26599631, 26745650, 26891492, 26891493, 26891495, 26891760, 26891765, 27081947, 27367346, 27367347, 27661666, 27669283, 27735227, 27735228, 27894534, 28471410, 28502670, 29308872",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the state of Indiana.",
            "Status": "recorded"
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