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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1771-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:    1. VALITUDE CRT-P EL, Model Number U125;   2. VALITUDE CRT-P EL MRI, Model Number U128;   3. VISIONIST CRT-P EL, Model Number U225;   4. VISIONIST CRT-P EL, Model Number U226;   5. VISIONIST CRT-P EL MRI, Model Number U228.",
  "description": "FDA recall Z-1771-2026 — Boston Scientific Corporation is recalling Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:    1. VALITUDE CRT-P EL, Model Number U125;   2. VALITUDE CRT-P EL MRI, Model Number U128;   3. VISIONIST CRT-P EL, Model Number U225;   4. VISIONIST CRT-P EL, Model Number U226;   5. VISIONIST CRT-P EL MRI, Model Number U228. (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "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-1771-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:    1. VALITUDE CRT-P EL, Model Number U125;   2. VALITUDE CRT-P EL MRI, Model Number U128;   3. VISIONIST CRT-P EL, Model Number U225;   4. VISIONIST CRT-P EL, Model Number U226;   5. VISIONIST CRT-P EL MRI, Model Number U228.",
    "manufacturer": {
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      "name": "Boston Scientific Corporation"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1771-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1771-2026: Boston Scientific Corporation is recalling Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:    1. VALITUDE CRT-P EL, Model Number U125;   2. VALITUDE CRT-P EL MRI, Model Number U128;   3. VISIONIST CRT-P EL, Model Number U225;   4. VISIONIST CRT-P EL, Model Number U226;   5. VISIONIST CRT-P EL MRI, Model Number U228.",
      "text": "The FDA logged enforcement record Z-1771-2026: Boston Scientific Corporation is voluntarily recalling Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:    1. VALITUDE CRT-P EL, Model Number U125;   2. VALITUDE CRT-P EL MRI, Model Number U128;   3. VISIONIST CRT-P EL, Model Number U225;   4. VISIONIST CRT-P EL, Model Number U226;   5. VISIONIST CRT-P EL MRI, Model Number U228. — reason: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE\" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices.    Dual chamber modes are specifically indicated for treatment of the following:    \" Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block    \" VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm    \" Low cardiac output or congestive heart failure secondary to bradycardia. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-19. Affected lots/codes: The advisory population includes all models listed; however, the bounding differs by battery type:   \"  All serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family are included in the advisory population.   \"  ACCOLADE DR-SL and SR-SLs with a use-by-date (UBD) on or before 30 June 2025 are included in the advisory population. Model number alone will not precisely identify individual DR-SL or SR-SL devices in the advisory population.   To determine if a device is affected, enter a model/serial into the device lookup tool at www.BostonScientific.com/lookup.. 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-1771-2026&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-1771-2026&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-1771-2026/fda-classification",
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      "name": "FDA classified recall Z-1771-2026 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-1771-2026&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-1771-2026&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-1771-2026/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)",
        "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."
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      "name": "FDA recall details — Z-1771-2026",
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          "item": {
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            "Value": "Z-1771-2026",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Boston Scientific Corporation",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE\" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices.    Dual chamber modes are specifically indicated for treatment of the following:    \" Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block    \" VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm    \" Low cardiac output or congestive heart failure secondary to bradycardia",
            "Status": "recorded"
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            "Field": "Initiated",
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            "Field": "Lot/code info",
            "Value": "The advisory population includes all models listed; however, the bounding differs by battery type:   \"  All serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family are included in the advisory population.   \"  ACCOLADE DR-SL and SR-SLs with a use-by-date (UBD) on or before 30 June 2025 are included in the advisory population. Model number alone will not precisely identify individual DR-SL or SR-SL devices in the advisory population.   To determine if a device is affected, enter a model/serial into the device lookup tool at www.BostonScientific.com/lookup.",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Distribution pattern",
            "Value": "worldwide",
            "Status": "recorded"
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}