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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0680-2025.jsonld",
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  "name": "Turbo Elite Laser Atherectomy Catheter  Model Number / UDI-DI code / Product Description  414-151 / 989930000531 / 1.4 mm OTW  417-152 / 989930000551 / 1.7 mm OTW  420-006 / 989930000571 / 2.0 mm OTW  423-001 / 989930000591 / 2.3 mm OTW  425-011 / 989930000601 / 2.5 mm OTW  423-135-01 / 989930004171 / 2.3 mm OTW  423-135-02 / 989930004181 / 2.3 mm OTW  425-135-01 / 989930004201 / 2.5 mm OTW  425-135-02 / 989930004211 / 2.5 mm OTW    The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.",
  "description": "FDA recall Z-0680-2025 — Spectranetics Corporation is recalling Turbo Elite Laser Atherectomy Catheter  Model Number / UDI-DI code / Product Description  414-151 / 989930000531 / 1.4 mm OTW  417-152 / 989930000551 / 1.7 mm OTW  420-006 / 989930000571 / 2.0 mm OTW  423-001 / 989930000591 / 2.3 mm OTW  425-011 / 989930000601 / 2.5 mm OTW  423-135-01 / 989930004171 / 2.3 mm OTW  423-135-02 / 989930004181 / 2.3 mm OTW  425-135-01 / 989930004201 / 2.5 mm OTW  425-135-02 / 989930004211 / 2.5 mm OTW    The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans. (Devices, Class II). 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": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Turbo Elite Laser Atherectomy Catheter  Model Number / UDI-DI code / Product Description  414-151 / 989930000531 / 1.4 mm OTW  417-152 / 989930000551 / 1.7 mm OTW  420-006 / 989930000571 / 2.0 mm OTW  423-001 / 989930000591 / 2.3 mm OTW  425-011 / 989930000601 / 2.5 mm OTW  423-135-01 / 989930004171 / 2.3 mm OTW  423-135-02 / 989930004181 / 2.3 mm OTW  425-135-01 / 989930004201 / 2.5 mm OTW  425-135-02 / 989930004211 / 2.5 mm OTW    The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.",
    "manufacturer": {
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      "name": "Spectranetics Corporation"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0680-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0680-2025: Spectranetics Corporation is recalling Turbo Elite Laser Atherectomy Catheter  Model Number / UDI-DI code / Product Description  414-151 / 989930000531 / 1.4 mm OTW  417-152 / 989930000551 / 1.7 mm OTW  420-006 / 989930000571 / 2.0 mm OTW  423-001 / 989930000591 / 2.3 mm OTW  425-011 / 989930000601 / 2.5 mm OTW  423-135-01 / 989930004171 / 2.3 mm OTW  423-135-02 / 989930004181 / 2.3 mm OTW  425-135-01 / 989930004201 / 2.5 mm OTW  425-135-02 / 989930004211 / 2.5 mm OTW    The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.",
      "text": "The FDA logged enforcement record Z-0680-2025: Spectranetics Corporation is voluntarily recalling Turbo Elite Laser Atherectomy Catheter  Model Number / UDI-DI code / Product Description  414-151 / 989930000531 / 1.4 mm OTW  417-152 / 989930000551 / 1.7 mm OTW  420-006 / 989930000571 / 2.0 mm OTW  423-001 / 989930000591 / 2.3 mm OTW  425-011 / 989930000601 / 2.5 mm OTW  423-135-01 / 989930004171 / 2.3 mm OTW  423-135-02 / 989930004181 / 2.3 mm OTW  425-135-01 / 989930004201 / 2.5 mm OTW  425-135-02 / 989930004211 / 2.5 mm OTW    The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans. — reason: Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-25. 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(01)00813132024710(17)250814(10)FAY23H0. 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-0680-2025&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-0680-2025&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-0680-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0680-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious 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.",
      "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-0680-2025&lang=eng",
        "value": "Class II",
        "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-0680-2025&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-0680-2025/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
      },
      "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."
    }
  ],
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      "name": "FDA recall details — Z-0680-2025",
      "numberOfItems": 9,
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          "item": {
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          "position": 4,
          "item": {
            "Field": "Status",
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        {
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
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            "Status": "recorded"
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        },
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.",
            "Status": "recorded"
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        },
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-25",
            "Status": "recorded"
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            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD TN, TX, UT, VA, WA, WI, and WV.  O.U.S.: Australia, Belgium, Brazil, China, Croatia, Cyprus, Czech Republic, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Poland, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}