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  "name": "Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080",
  "description": "FDA recall Z-1644-2025 — Abbott is recalling Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 (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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      "name": "FDA recall Z-1644-2025: Abbott is recalling Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080",
      "text": "The FDA logged enforcement record Z-1644-2025: Abbott is voluntarily recalling Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 — reason: Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-17. Affected lots/codes: UDI-DI 00811806012926 Lots 9078966 9093895 9134623 9144113 9148110 9148579 9155868 9158302 9241591 9241593 10004059 10011461 10011462 10011463 10011465 10017790 10017792 10196106 10196119 10198795 10198801 10198889 10207472 10207503 10274454 10283818. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1644-2025 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.",
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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.",
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      "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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