{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2224-2023.jsonld", "@type": "schema:Dataset", "name": "REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr.\tD684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr.\tD684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.\tD684-00-0403-10", "description": "FDA recall Z-2224-2023 — Datascope Corp. is recalling REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr.\tD684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr.\tD684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.\tD684-00-0403-10 (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.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2224-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr.\tD684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr.\tD684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.\tD684-00-0403-10", "manufacturer": { "@type": "schema:Organization", "name": "Datascope Corp." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2224-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-2224-2023: Datascope Corp. is recalling REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr.\tD684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr.\tD684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.\tD684-00-0403-10", "text": "The FDA logged enforcement record Z-2224-2023: Datascope Corp. is voluntarily recalling REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr.\tD684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr.\tD684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.\tD684-00-0403-10 — reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-23. Affected lots/codes: Product Description UDI REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. 10607567106656 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. 10607567106694 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. 10607567107943. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2224-2023&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2224-2023&lang=eng" } }, "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." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2224-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-2224-2023 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.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2224-2023&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2224-2023&lang=eng" } }, "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." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2224-2023/boundary", "@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. 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A flat representation would render this identically to the official facts; the four-status does not." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-2224-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-2224-2023", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Datascope Corp.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2023-06-23", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Product Description UDI REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. 10607567106656 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. 10607567106694 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. 10607567107943", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Domestic distribution nationwide. International distribution worldwide.", "Status": "recorded" } } ] } ] }