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  "name": "Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6",
  "description": "FDA recall Z-0320-2024 — Medtronic Inc is recalling Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 (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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      "name": "FDA recall Z-0320-2024: Medtronic Inc is recalling Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6",
      "text": "The FDA logged enforcement record Z-0320-2024: Medtronic Inc is voluntarily recalling Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 — reason: The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units\u0019 manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-12. Affected lots/codes: UDI/DI 08033477090719:   UDI/DI 00763000451691. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0320-2024 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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      "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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      "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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