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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0552-2025.jsonld",
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  "name": "Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150    Merlin@home with the MerlinOnDemand\" (MoD) capability is a transmitter  configured for multiple patient use. It can receive information from an  implantable heart device in unpaired mode. With MoD capability, the transmitter  will retrieve full follow-up data or retrieve data for display on the Merlin.net\"  Patient Care Network (PCN). The MoD capability enables clinicians to do the  following:  . support remote care patients in emergency rooms and heart failure clinics  . triage patients for in clinic follow-ups  . support patients in a clinical setting with Merlin.net PCN",
  "description": "FDA recall Z-0552-2025 — Abbott Medical is recalling Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150    Merlin@home with the MerlinOnDemand\" (MoD) capability is a transmitter  configured for multiple patient use. It can receive information from an  implantable heart device in unpaired mode. With MoD capability, the transmitter  will retrieve full follow-up data or retrieve data for display on the Merlin.net\"  Patient Care Network (PCN). The MoD capability enables clinicians to do the  following:  . support remote care patients in emergency rooms and heart failure clinics  . triage patients for in clinic follow-ups  . support patients in a clinical setting with Merlin.net PCN (Devices, Class III). 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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      "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-0552-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150    Merlin@home with the MerlinOnDemand\" (MoD) capability is a transmitter  configured for multiple patient use. It can receive information from an  implantable heart device in unpaired mode. With MoD capability, the transmitter  will retrieve full follow-up data or retrieve data for display on the Merlin.net\"  Patient Care Network (PCN). The MoD capability enables clinicians to do the  following:  . support remote care patients in emergency rooms and heart failure clinics  . triage patients for in clinic follow-ups  . support patients in a clinical setting with Merlin.net PCN",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Abbott Medical"
    }
  },
  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0552-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0552-2025: Abbott Medical is recalling Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150    Merlin@home with the MerlinOnDemand\" (MoD) capability is a transmitter  configured for multiple patient use. It can receive information from an  implantable heart device in unpaired mode. With MoD capability, the transmitter  will retrieve full follow-up data or retrieve data for display on the Merlin.net\"  Patient Care Network (PCN). The MoD capability enables clinicians to do the  following:  . support remote care patients in emergency rooms and heart failure clinics  . triage patients for in clinic follow-ups  . support patients in a clinical setting with Merlin.net PCN",
      "text": "The FDA logged enforcement record Z-0552-2025: Abbott Medical is voluntarily recalling Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150    Merlin@home with the MerlinOnDemand\" (MoD) capability is a transmitter  configured for multiple patient use. It can receive information from an  implantable heart device in unpaired mode. With MoD capability, the transmitter  will retrieve full follow-up data or retrieve data for display on the Merlin.net\"  Patient Care Network (PCN). The MoD capability enables clinicians to do the  following:  . support remote care patients in emergency rooms and heart failure clinics  . triage patients for in clinic follow-ups  . support patients in a clinical setting with Merlin.net PCN — reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-01. Affected lots/codes: Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "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-0552-2025&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-0552-2025&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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      "name": "FDA classified recall Z-0552-2025 as Class III",
      "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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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        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class III",
        "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-0552-2025&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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0552-2025/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-0552-2025",
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            "Value": "Z-0552-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class III",
            "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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Abbott Medical",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.",
            "Status": "recorded"
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            "Value": "2024-10-01",
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          "item": {
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            "Value": "Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.",
            "Status": "recorded"
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}