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  "name": "ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use   ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011",
  "description": "FDA recall Z-2587-2024 — Inari Medical - Oak Canyon is recalling ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use   ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011 (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use   ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011",
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      "name": "FDA recall Z-2587-2024: Inari Medical - Oak Canyon is recalling ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use   ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011",
      "text": "The FDA logged enforcement record Z-2587-2024: Inari Medical - Oak Canyon is voluntarily recalling ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use   ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011 — reason: Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-19. Affected lots/codes: UDI-DI:00850291007277. All lots. IU-01011 REV. C.. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-2587-2024 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.",
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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."
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    {
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      "@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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        "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": "Reason",
            "Value": "Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.",
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            "Status": "recorded"
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