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  "name": "SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta      Product Description                                                                      Part Number    SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0469-01C  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0469-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0470-01C  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0470-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0470-09  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES\t                   D684-00-0470-01  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0470-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0469-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES\t                   D684-00-0469-01  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY\t      D684-00-0469-09  PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs\tD884-00-0019-16",
  "description": "FDA recall Z-2217-2023 — Datascope Corp. is recalling SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta      Product Description                                                                      Part Number    SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0469-01C  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0469-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0470-01C  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0470-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0470-09  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES\t                   D684-00-0470-01  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0470-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0469-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES\t                   D684-00-0469-01  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY\t      D684-00-0469-09  PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs\tD884-00-0019-16 (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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    "@type": "schema:MedicalDevice",
    "name": "SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta      Product Description                                                                      Part Number    SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0469-01C  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0469-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0470-01C  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0470-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0470-09  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES\t                   D684-00-0470-01  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0470-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0469-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES\t                   D684-00-0469-01  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY\t      D684-00-0469-09  PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs\tD884-00-0019-16",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Datascope Corp."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2217-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2217-2023: Datascope Corp. is recalling SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta      Product Description                                                                      Part Number    SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0469-01C  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0469-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0470-01C  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0470-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0470-09  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES\t                   D684-00-0470-01  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0470-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0469-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES\t                   D684-00-0469-01  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY\t      D684-00-0469-09  PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs\tD884-00-0019-16",
      "text": "The FDA logged enforcement record Z-2217-2023: Datascope Corp. is voluntarily recalling SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta      Product Description                                                                      Part Number    SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0469-01C  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0469-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0470-01C  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0470-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0470-09  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES\t                   D684-00-0470-01  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0470-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0469-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES\t                   D684-00-0469-01  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY\t      D684-00-0469-09  PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs\tD884-00-0019-16 — reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-23. Affected lots/codes: Product Description                                                                                       UDI SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)       10607567109367 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)       10607567109732 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)       10607567109374 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)       10607567109749 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113135 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES                    10607567106779 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10607567109541 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES                    10607567106755 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY        10607567113128 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs    10607567106724. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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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-2217-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-2217-2023&lang=eng"
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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-2217-2023/fda-classification",
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      "name": "FDA classified recall Z-2217-2023 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.",
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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-2217-2023",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2217-2023",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Datascope Corp.",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-06-23",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Product Description                                                                                       UDI SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)       10607567109367 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)       10607567109732 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)       10607567109374 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)       10607567109749 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113135 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES                    10607567106779 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10607567109541 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES                    10607567106755 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY        10607567113128 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs    10607567106724",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Domestic distribution nationwide. International distribution worldwide.",
            "Status": "recorded"
          }
        }
      ]
    }
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}