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  "name": "Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:  S 6 F x 110 cm, REF: 80236;  S 6 F x 135 cm, REF: 80237;  S 8 F x 85 cm, REF: 80238;  S 8 F x 110 cm, REF: 80239",
  "description": "FDA recall Z-1244-2025 — Bard Peripheral Vascular Inc is recalling Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:  S 6 F x 110 cm, REF: 80236;  S 6 F x 135 cm, REF: 80237;  S 8 F x 85 cm, REF: 80238;  S 8 F x 110 cm, REF: 80239 (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": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:  S 6 F x 110 cm, REF: 80236;  S 6 F x 135 cm, REF: 80237;  S 8 F x 85 cm, REF: 80238;  S 8 F x 110 cm, REF: 80239",
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      "name": "Bard Peripheral Vascular Inc"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1244-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1244-2025: Bard Peripheral Vascular Inc is recalling Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:  S 6 F x 110 cm, REF: 80236;  S 6 F x 135 cm, REF: 80237;  S 8 F x 85 cm, REF: 80238;  S 8 F x 110 cm, REF: 80239",
      "text": "The FDA logged enforcement record Z-1244-2025: Bard Peripheral Vascular Inc is voluntarily recalling Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:  S 6 F x 110 cm, REF: 80236;  S 6 F x 135 cm, REF: 80237;  S 8 F x 85 cm, REF: 80238;  S 8 F x 110 cm, REF: 80239 — reason: Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-05. Affected lots/codes: Instructions for Use versions prior to ZE10895 revision C1 09/24.  REF/UDI-DI/Lot(Expiration):  80236/07640142811855/230893(2025-12-15), 231100(2026-06-09), 231172(2026-06-09), 231171(2026-06-09), 231526(2026-08-21), 231875(2026-08-21), 240018(2026-11-22), 240017(2026-11-22), 240375(2027-01-18), 240567(2027-01-18), 241075(2024-05-22), 241335(2024-06-19), 241550(2024-07-19), 241777(2024-08-19), 242691(2024-12-13);  80237/07640142811862/230897(2026-04-11), 230898(2026-04-11), 231033(2026-05-31), 231101(2026-06-13), 231170(2026-06-13), 231229(2026-07-07), 231400(2026-07-14), 231414(2026-07-31), 231412(2026-06-30), 231413(2026-07-31), 231411(2026-08-03), 231521(2026-09-01), 231520(2026-07-31), 231522(2026-08-31), 231523(2026-09-01), 231524(2026-09-01), 231525(2026-09-01), 231715(2026-09-22), 231885(2026-09-22), 231884(2026-10-27), 240020(2026-11-22), 240396(2026-12-08), 240530(2027-01-10), 240531(2027-01-10), 240566(2027-01-10), 240568(2027-01-25), 240754(2027-02-06), 240769(2027-02-09), 240795(2027-03-04), 241074(2027-03-07), 241119(2027-03-21), 241190(2027-04-16), 241325(2027-04-16), 241328(2027-04-25), 241336(2027-04-29), 241464(2027-05-07), 241471(2027-05-27), 241553(2027-06-05), 242019(2027-06-28), 242023(2027-06-12), 242057(2027-06-20), 242056(2027-06-20), 242112(2027-06-26), 242160(2027-07-25), 242321(2027-07-08), 242493(2027-08-01), 242596(2027-09-20), 242693(2027-11-06);  80238/07640142811879/230895(2025-11-23), 240128(2026-05-31), 240276(2026-05-31), 240532(2026-05-31), 240658(2026-09-30), 241076(2026-09-30), 241330(2026-09-30), 241548(2026-09-30), 241768(2026-09-30), 241911(2026-09-30), 242117(2026-09-30), 242494(2026-09-30), 242521(2026-09-30), 242519(2026-05-31), 242520(2026-09-30);  80239/07640142811886/230896(2025-11-23), 231231(2026-06-13), 231410(2026-06-13), 231527(2026-08-31), 231883(2026-10-19), 232029(2026-08-31), 232028(2026-10-19), 240129(2026-11-30), 240278(2026-11-30), 240557(2027-01-22), 240746(2027-01-22), 240794(2027-02-28), 241077(2027-04-08), 241188(2027-04-08), 241462(2027-05-03), 241523(2027-05-03), 241767(2027-06-26), 241910(2027-06-26), 242159(2027-08-09), 242322(2027-09-10), 242518(2027-09-10), 242694(2027-10-25), 242695(2027-10-25). A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
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        "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-1244-2025&lang=eng",
        "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1244-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1244-2025 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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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class I",
        "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-1244-2025&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-1244-2025/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",
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        "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-1244-2025",
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            "Value": "Z-1244-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Bard Peripheral Vascular Inc",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-02-05",
            "Status": "recorded"
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          "position": 8,
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            "Field": "Lot/code info",
            "Value": "Instructions for Use versions prior to ZE10895 revision C1 09/24.  REF/UDI-DI/Lot(Expiration):  80236/07640142811855/230893(2025-12-15), 231100(2026-06-09), 231172(2026-06-09), 231171(2026-06-09), 231526(2026-08-21), 231875(2026-08-21), 240018(2026-11-22), 240017(2026-11-22), 240375(2027-01-18), 240567(2027-01-18), 241075(2024-05-22), 241335(2024-06-19), 241550(2024-07-19), 241777(2024-08-19), 242691(2024-12-13);  80237/07640142811862/230897(2026-04-11), 230898(2026-04-11), 231033(2026-05-31), 231101(2026-06-13), 231170(2026-06-13), 231229(2026-07-07), 231400(2026-07-14), 231414(2026-07-31), 231412(2026-06-30), 231413(2026-07-31), 231411(2026-08-03), 231521(2026-09-01), 231520(2026-07-31), 231522(2026-08-31), 231523(2026-09-01), 231524(2026-09-01), 231525(2026-09-01), 231715(2026-09-22), 231885(2026-09-22), 231884(2026-10-27), 240020(2026-11-22), 240396(2026-12-08), 240530(2027-01-10), 240531(2027-01-10), 240566(2027-01-10), 240568(2027-01-25), 240754(2027-02-06), 240769(2027-02-09), 240795(2027-03-04), 241074(2027-03-07), 241119(2027-03-21), 241190(2027-04-16), 241325(2027-04-16), 241328(2027-04-25), 241336(2027-04-29), 241464(2027-05-07), 241471(2027-05-27), 241553(2027-06-05), 242019(2027-06-28), 242023(2027-06-12), 242057(2027-06-20), 242056(2027-06-20), 242112(2027-06-26), 242160(2027-07-25), 242321(2027-07-08), 242493(2027-08-01), 242596(2027-09-20), 242693(2027-11-06);  80238/07640142811879/230895(2025-11-23), 240128(2026-05-31), 240276(2026-05-31), 240532(2026-05-31), 240658(2026-09-30), 241076(2026-09-30), 241330(2026-09-30), 241548(2026-09-30), 241768(2026-09-30), 241911(2026-09-30), 242117(2026-09-30), 242494(2026-09-30), 242521(2026-09-30), 242519(2026-05-31), 242520(2026-09-30);  80239/07640142811886/230896(2025-11-23), 231231(2026-06-13), 231410(2026-06-13), 231527(2026-08-31), 231883(2026-10-19), 232029(2026-08-31), 232028(2026-10-19), 240129(2026-11-30), 240278(2026-11-30), 240557(2027-01-22), 240746(2027-01-22), 240794(2027-02-28), 241077(2027-04-08), 241188(2027-04-08), 241462(2027-05-03), 241523(2027-05-03), 241767(2027-06-26), 241910(2027-06-26), 242159(2027-08-09), 242322(2027-09-10), 242518(2027-09-10), 242694(2027-10-25), 242695(2027-10-25)",
            "Status": "recorded"
          }
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA, MS, MI, TX, KS, IL, CA, GA, OH, AL, NC, ND, AZ, SC, TN, UT, AR, WI, SD, MA, MO, ME, DE, WV , NV, NH, MN, CT, NE, IA, NM, WA, HI, and OK",
            "Status": "recorded"
          }
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