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  "name": "ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;",
  "description": "FDA recall Z-2967-2024 — Abiomed, Inc. is recalling ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; (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-2967-2024: Abiomed, Inc. is recalling ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;",
      "text": "The FDA logged enforcement record Z-2967-2024: Abiomed, Inc. is voluntarily recalling ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; — reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-05. Affected lots/codes: Product Code: 1000302; UDI-DI: 00813502012767; Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669; Batch Numbers: 2023263121 2023263124 2023263125 2023269641 2023269670 2023269672 2023269673 2023269674;. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2967-2024 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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