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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1379-2023.jsonld",
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  "name": "Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)",
  "description": "FDA recall Z-1379-2023 — Edwards Lifesciences, LLC is recalling Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm) (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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    "name": "Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)",
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      "name": "Edwards Lifesciences, LLC"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1379-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1379-2023: Edwards Lifesciences, LLC is recalling Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)",
      "text": "The FDA logged enforcement record Z-1379-2023: Edwards Lifesciences, LLC is voluntarily recalling Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm) — reason: There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-14. Affected lots/codes: Primary DI Number: 00690103146554/ Lot: 64191420 64228620 64229652 64238028 64238630 64243142 64243143 64260684 64260685 64262168 64264946 64278346 64289390 64289391 64289408 64304361 64304362 64304363 64314476 64314477 64314479 64320628 64325327 64328112 64328113 64328114 64328115 64337979 64337980 64337981 64345011 64345012 64355442 64362238 64362239 64362240 64362241 64362242 64373343 64373344 64373345 64381703 64383275 64383276 64383277 64385609 64385610 64385611 64385612 64385613 64398982 64398983 64398984 64410910 64410911 64410912 64410913 64410914 64423626 64423627 64423628 64423629 64423630 64430338 64430339 64430340 64446892 64446893 64446894 64446895 64458777 64458778 64458779 64462548 64462549 64470780 64470781 64470782 64470783 64478098 64478099 64483100 64483101 64483102 64483103 64483104 64496490 64496491 64514042 64540629 64540630 64540631 64552372 64577637 64578749 64578750 64584948 64584949 64584950 64584951 64584952 64603534 64609691 64613340 64617864 64623071 64636398 64664097 64664390 64742870 64746321 64746322 64762706 64769085. 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-1379-2023/fda-classification",
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      "name": "FDA classified recall Z-1379-2023 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,
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        "adjudged": 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."
    },
    {
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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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        "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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            "Field": "Reason",
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            "Value": "Primary DI Number: 00690103146554/ Lot: 64191420 64228620 64229652 64238028 64238630 64243142 64243143 64260684 64260685 64262168 64264946 64278346 64289390 64289391 64289408 64304361 64304362 64304363 64314476 64314477 64314479 64320628 64325327 64328112 64328113 64328114 64328115 64337979 64337980 64337981 64345011 64345012 64355442 64362238 64362239 64362240 64362241 64362242 64373343 64373344 64373345 64381703 64383275 64383276 64383277 64385609 64385610 64385611 64385612 64385613 64398982 64398983 64398984 64410910 64410911 64410912 64410913 64410914 64423626 64423627 64423628 64423629 64423630 64430338 64430339 64430340 64446892 64446893 64446894 64446895 64458777 64458778 64458779 64462548 64462549 64470780 64470781 64470782 64470783 64478098 64478099 64483100 64483101 64483102 64483103 64483104 64496490 64496491 64514042 64540629 64540630 64540631 64552372 64577637 64578749 64578750 64584948 64584949 64584950 64584951 64584952 64603534 64609691 64613340 64617864 64623071 64636398 64664097 64664390 64742870 64746321 64746322 64762706 64769085",
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            "Field": "Distribution pattern",
            "Value": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tWA\tWI\tWV\tWY OUS: None",
            "Status": "recorded"
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