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  "name": "DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110",
  "description": "FDA recall Z-2481-2025 — Medtronic Perfusion Systems is recalling DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 (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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    "name": "DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110",
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      "name": "FDA recall Z-2481-2025: Medtronic Perfusion Systems is recalling DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110",
      "text": "The FDA logged enforcement record Z-2481-2025: Medtronic Perfusion Systems is voluntarily recalling DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 — reason: The catheters may not retain their shape.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-06. Affected lots/codes: UDI-DI: 20643169880676, 00643169880672, 00673978176468, 00763000946432, 20763000946436;  Serial Numbers: 2023120708 2023120708 2023120709 2023120710 2023120711 2023120712 2023121041 2023121041 2023121042 2024011203 2024011203 2024011204 2024020135 2024020136 2024020137 2024020138 2024020138 2024020139 2024020140 2024020141 2024020141 2024020471 2024020472 2024020473 2024020474 2024020474 2024020474 2024020475 2024020475 2024020475 2024020806 2024020806 2024020806 2024030359 2024030360 2024030360 2024030361 2024030361 2024030361 2024030833 2024030833 2024030834 2024030834 2024030835 2024030835 2024031088 2024031088 2024050074 2024050075 2024050076 2024050403 2024050404 2024050761 2024050762 2024050763 2024050763 2024051075 2024051076 2024051265 2024060283 2024060284 2024060284 2024060285 2024060529 2024070340 2024070340 2024071120 2024071120 2024071121 2024071121 2024071122 2024071122 2024080225 2024080225 2024080465 2024080465 2024080690 2024081023 2024081024 2024090228 2024090229 2024090470 2024090470 2024090471 2024090767 2024090768 2024100621 2024100622 202312C204 202312C205 202401C295 202401C296 202403C144 202403C145 202403C146 202405C079 202405C080 202406C064 202406C065 202406C066 202409C128. A RECORDED FDA enforcement action (occurred=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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      "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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