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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0110-2026.jsonld",
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  "name": "TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter",
  "description": "FDA recall Z-0110-2026 — Abbott is recalling TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter (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": "TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0110-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0110-2026: Abbott is recalling TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter",
      "text": "The FDA logged enforcement record Z-0110-2026: Abbott is voluntarily recalling TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter — reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-10. Affected lots/codes: GTIN 05415067034557, Batch Numbers:  8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195, 8947323, 8949324, 8958968, 8959452, 8960986, 8961409, 8963254, 8965484, 8965486, 8991236, 8993365, 9001917, 9003044, 9003047, 9012222, 9013428, 9015293, 9038354, 9039239, 9065946, 9066884, 9071294, 9119487, 9138236, 9147733, 9148411, 9156153, 9158891, 10162247, 10173398, 10205310, 10207502, 10218030, 10228449, 10228450, 10230429, 10232940, 10235434, 10235436, 10240235, 10242138, 10242992, 10242995, 10280672, 10288053, 10288057, 10289553, 10289668, 10289709, 10289759, 10297899, 10334695, 10334845, 10338853, 10338856, 10343551, 10360411, 10375524, 10382430, 10384530, 10384531, 10395601, 10395605, 10449220, 10451314, 10451768, 10451769, 10458698, 10465076, 10465083, 10465086, 10466761, 10469707, 10509213, 10565373, 10565827, 10566663, 10599493, 10600697, 10601488, 10610624, 10615028, 10628998, 10629000, 10638074, 10638488, 10639808, 10641833, 10645657, 10651462, 10651463, 10652440, 10657253, 10696081, 10696560, 10696907, 10705798, 10737121, 10737122, 10737249, 10737251, 10741862, 10742337, 10742342, 10744906, 10748214, 10748215, 10748680, 10749783, 10749788, 10749790, 10763049, 10763071, 10765654, 10780658, 10780710, 10781495, 10781677, 10788527, 10792081, 10792406, 10792407, 10793780, 10799615, 10799616, 10805125, 10805367, 10805369, 10805370, 10805371, 10813353, 10834650, 10844788, 10850740, 10850746, 10851557, 10855920, 10855921, 10868920, 10868921, 10893531, 10978587, 10978588, 11017094, 11017095, 11034753.. 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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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0110-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0110-2026 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": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0110-2026/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.",
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      "commercialInfluence": false,
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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-0110-2026",
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