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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2325-2025.jsonld",
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  "name": "ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187",
  "description": "FDA recall Z-2325-2025 — Boston Scientific Corporation is recalling ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187 (Devices, Class I). 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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    "creator": {
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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-2325-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Boston Scientific Corporation"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2325-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2325-2025: Boston Scientific Corporation is recalling ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187",
      "text": "The FDA logged enforcement record Z-2325-2025: Boston Scientific Corporation is voluntarily recalling ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187 — reason: Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-24. Affected lots/codes: Model 0161 UDI-DI/GTIN 00802526372766;  Model 0164 UDI-DI/GTIN N/A;  Model 0165 UDI-DI/GTIN 00802526377259;  Model 0167 UDI-DI/GTIN N/A 00802526373251;  Model 0170 UDI-DI/GTIN 00802526373282 00802526373299;  Model 0171 UDI-DI/GTIN  00802526373374 00802526373381;  Model 0172 UDI-DI/GTIN 00802526373466;  Model 0173 UDI-DI/GTIN 00802526373558 00802526373565;  Model 0174 UDI-DI/GTIN  00802526373640;  Model 0175 UDI-DI/GTIN 00802526373732 00802526373749;  Model 0176 UDI-DI/GTIN  00802526376726 00802526376733;  Model 0177 UDI-DI/GTIN 00802526376818 00802526376825;  Model 0180 UDI-DI/GTIN 00802526411977 00802526422027 00802526433597 00802526531149 00802526540943 00802526540950 00802526591518;  Model 0181 UDI-DI/GTIN 00802526411984 00802526422034 00802526433689 00802526433726 00802526433757 00802526491009 00802526502903 00802526531156;  Model 0182 UDI-DI/GTIN 00802526422041 00802526531163;  Model 0183 UDI-DI/GTIN 00802526422058 00802526531170;  Model 0184 UDI-DI/GTIN 00802526412011 00802526422065 00802526433986 00802526433993 00802526491313 00802526531187 00802526541261 00802526583438;  Model 0185 UDI-DI/GTIN 00802526412028 00802526413438 00802526422072 00802526434082 00802526434099 00802526434105 00802526434150 00802526434174 00802526470622 00802526491405 00802526491412 00802526491429 00802526503306 00802526531194 00802526541346 00802526591563 00802526612541;  Model 0186 UDI-DI/GTIN 00802526412035 00802526422089 00802526434198 00802526531200;  Model 0187 UDI-DI/GTIN 00802526412042 00802526422096 00802526531217. 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-2325-2025&lang=eng",
        "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-2325-2025&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2325-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2325-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2325-2025&lang=eng",
        "value": "Class I",
        "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-2325-2025&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-2325-2025/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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2325-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2325-2025",
            "Status": "recorded"
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        {
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Boston Scientific Corporation",
            "Status": "recorded"
          }
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-07-24",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model 0161 UDI-DI/GTIN 00802526372766;  Model 0164 UDI-DI/GTIN N/A;  Model 0165 UDI-DI/GTIN 00802526377259;  Model 0167 UDI-DI/GTIN N/A 00802526373251;  Model 0170 UDI-DI/GTIN 00802526373282 00802526373299;  Model 0171 UDI-DI/GTIN  00802526373374 00802526373381;  Model 0172 UDI-DI/GTIN 00802526373466;  Model 0173 UDI-DI/GTIN 00802526373558 00802526373565;  Model 0174 UDI-DI/GTIN  00802526373640;  Model 0175 UDI-DI/GTIN 00802526373732 00802526373749;  Model 0176 UDI-DI/GTIN  00802526376726 00802526376733;  Model 0177 UDI-DI/GTIN 00802526376818 00802526376825;  Model 0180 UDI-DI/GTIN 00802526411977 00802526422027 00802526433597 00802526531149 00802526540943 00802526540950 00802526591518;  Model 0181 UDI-DI/GTIN 00802526411984 00802526422034 00802526433689 00802526433726 00802526433757 00802526491009 00802526502903 00802526531156;  Model 0182 UDI-DI/GTIN 00802526422041 00802526531163;  Model 0183 UDI-DI/GTIN 00802526422058 00802526531170;  Model 0184 UDI-DI/GTIN 00802526412011 00802526422065 00802526433986 00802526433993 00802526491313 00802526531187 00802526541261 00802526583438;  Model 0185 UDI-DI/GTIN 00802526412028 00802526413438 00802526422072 00802526434082 00802526434099 00802526434105 00802526434150 00802526434174 00802526470622 00802526491405 00802526491412 00802526491429 00802526503306 00802526531194 00802526541346 00802526591563 00802526612541;  Model 0186 UDI-DI/GTIN 00802526412035 00802526422089 00802526434198 00802526531200;  Model 0187 UDI-DI/GTIN 00802526412042 00802526422096 00802526531217",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution. US nationwide. International distribution worldwide.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}