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  "name": "Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system",
  "description": "FDA recall Z-1390-2024 — Boston Scientific Corporation is recalling Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system (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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    "name": "Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1390-2024/enforcement-record",
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      "name": "FDA recall Z-1390-2024: Boston Scientific Corporation is recalling Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system",
      "text": "The FDA logged enforcement record Z-1390-2024: Boston Scientific Corporation is voluntarily recalling Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system — reason: Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-20. Affected lots/codes: GTIN 08714729950660, Batch Numbers:  31368041, 31390084, 31390088, 31390089, 31501866, 31501867, 31501868,  31501869, 31520897, 31520898, 31604492, 31616143, 31633635, 31650457, 31664216, 31664217, 31671140, 31671143, 31693638, 31693639, 31724952, 31732930, 31732931, 31740806, 31740807, 31740808, 31751118, 31777134, 31786582, 31786583, 31818290, 31818299, 31818341, 31818342, 31818343, 31818344, 31818345, 31818346, 31818347, 31838684, 31838685, 31838686, 31838687, 31838688, 31838689, 31877302, 31877304, 31877305, 31877306, 31904748, 31904749, 31923755, 31923756, 31953345, 31953348, 32008170, 32031191, 32031192, 32031193, 32031196, 32059171, 32059386, 32059387, 32059388, 32059392, 32059393, 32059394, 32059396, 32059397, 32212151, 32212153, 32230544, 32230545, 32230546, 32230547, 32230548, 32230549, 32230550, 32230551, 32284196, 32284198, 32284200, 32304326, 32304327, 32304328, 32313757, 32313758, 32313759, 32322405, 32322406, 32322407, 32331162, 32331163, 32331164, 32331165, 32427040, 32452794, 32461848, 32461849, 32461850, 32470848, 32470849, 32480089, 32480090, 32481344, 32481345, 32522178, 32530450, 32530451, 32602892, 32602893, 32611557, 32611558, 32611559, 32620708, 32620709, 32620710, 32629426, 32642560,  32642561. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1390-2024 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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      "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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            "Value": "Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.",
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