{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1591-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:     1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.     3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.    4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.     6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.     7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.     8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.     9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.",
  "description": "FDA recall Z-1591-2026 — Abiomed, Inc. is recalling Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:     1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.     3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.    4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.     6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.     7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.     8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.     9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1591-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:     1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.     3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.    4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.     6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.     7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.     8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.     9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Abiomed, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1591-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1591-2026: Abiomed, Inc. is recalling Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:     1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.     3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.    4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.     6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.     7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.     8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.     9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.",
      "text": "The FDA logged enforcement record Z-1591-2026: Abiomed, Inc. is voluntarily recalling Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:     1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.     3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.    4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.     6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.     7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.     8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.     9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. — reason: Potential that the \"Purge System Blocked\"  alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-16. Affected lots/codes: All products below with software version 8.2.2 through 8.5 are affected.  1. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416.   2. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581.  3. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312.  4. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140.  5. Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683.   6. Product Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440.   7. Product Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894.   8. Product Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425.   9. Product Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-1591-2026&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-1591-2026&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1591-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1591-2026 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
      },
      "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-1591-2026&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-1591-2026&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-1591-2026/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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "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": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1591-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1591-2026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Abiomed, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential that the \"Purge System Blocked\"  alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-02-16",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All products below with software version 8.2.2 through 8.5 are affected.  1. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416.   2. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581.  3. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312.  4. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140.  5. Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683.   6. Product Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440.   7. Product Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894.   8. Product Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425.   9. Product Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "International distribution in the country of Australia, Canada, France, Germany, Kuwait.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}