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  "name": "The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following:  1. VasoView Hemopro 2, Model Number: VH-4000.  2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001.  The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws.  One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery.  An area near the tip of the convex side of the jaw is used for spot cautery.  The activation toggle is used to control the jaws to activate the heating elements.  Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.",
  "description": "FDA recall Z-2175-2024 — Maquet Cardiovascular, LLC is recalling The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following:  1. VasoView Hemopro 2, Model Number: VH-4000.  2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001.  The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws.  One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery.  An area near the tip of the convex side of the jaw is used for spot cautery.  The activation toggle is used to control the jaws to activate the heating elements.  Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. (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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    "@type": "schema:MedicalDevice",
    "name": "The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following:  1. VasoView Hemopro 2, Model Number: VH-4000.  2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001.  The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws.  One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery.  An area near the tip of the convex side of the jaw is used for spot cautery.  The activation toggle is used to control the jaws to activate the heating elements.  Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.",
    "manufacturer": {
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      "name": "Maquet Cardiovascular, LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2175-2024/enforcement-record",
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      "name": "FDA recall Z-2175-2024: Maquet Cardiovascular, LLC is recalling The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following:  1. VasoView Hemopro 2, Model Number: VH-4000.  2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001.  The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws.  One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery.  An area near the tip of the convex side of the jaw is used for spot cautery.  The activation toggle is used to control the jaws to activate the heating elements.  Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.",
      "text": "The FDA logged enforcement record Z-2175-2024: Maquet Cardiovascular, LLC is voluntarily recalling The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following:  1. VasoView Hemopro 2, Model Number: VH-4000.  2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001.  The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws.  One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery.  An area near the tip of the convex side of the jaw is used for spot cautery.  The activation toggle is used to control the jaws to activate the heating elements.  Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. — reason: Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-17. Affected lots/codes: 1. Model Number: VH-4000. UDI-DI: 00607567700406. All lot numbers within expiration.  2. Model Number: VH-4001. UDI-DI: 00607567700451. All lot numbers within expiration.. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2175-2024&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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      "name": "FDA classified recall Z-2175-2024 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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      "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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            "Value": "Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.",
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            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom.",
            "Status": "recorded"
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