{ "@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-1727-2023.jsonld", "@type": "schema:Dataset", "name": "ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators", "description": "FDA recall Z-1727-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators (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.", "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-1727-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators", "manufacturer": { "@type": "schema:Organization", "name": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1727-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1727-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators", "text": "The FDA logged enforcement record Z-1727-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators — reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-10. Affected lots/codes: GTIN 00763000178413, Lot Serial Numbers: RSP600249S, RSP600057S, RSP600253S, RSP600085S, RSP600014S, RSP600150S, RSP600148S, RSP600089S, RSP600091S, RSP600114S, RSP600189S, RSP600210S, RSP600394S, RSP600130S, RSP600216S, RSP600256S, RSP600386S, RSP600149S, RSP600245S, RSP600066S, RSP600068S, RSP600069S, RSP600083S, RSP600112S, RSP600132S, RSP600136S, RSP600404S, RSP600076S, RSP600731S, RSP600954S, RSP600955S, RSP600953S, RSP600070S, RSP600145S, RSP600157S, RSP600200S, RSP600226S, RSP600082S, RSP600139S, RSP600141S, RSP600152S, RSP600163S, RSP600074S, RSP600732S, RSP600204S, RSP600369S, RSP600726S, RSP600748S, RSP600048S, RSP600080S, RSP600363S, RSP600396S, RSP600397S, RSP600408S, RSP600444S, RSP600544S, RSP600335S, RSP600383S, RSP600400S, RSP600808S, RSP600862S, RSP600939S, RSP600949S, RSP600950S, RSP600218S, RSP600288S, RSP600246S, RSP600193S, RSP600395S, RSP600725S, RSP600360S, RSP600413S, RSP600202S, RSP600736S, RSP600138S, RSP600049S, RSP600065S, RSP600095S, RSP600346S, RSP600372S, RSP600059S, RSP600219S, RSP600079S, RSP600190S, RSP600398S, RSP600217S, RSP600230S, RSP600723S, RSP600203S, RSP600221S, RSP600187S, RSP600250S, RSP600276S, RSP600060S, RSP600267S, RSP600392S, RSP600813S, RSP600154S, RSP600209S, RSP600211S, RSP600224S, RSP600729S, RSP600758S, RSP600134S, RSP600096S, RSP600734S, RSP600273S, RSP600722S, RSP600945S, RSP600946S; GTIN 00763000178420, Lot Serial Numbers: RSP600738S, RSP601022S, RSP600759S, RSP600761S, RSP600976S, RSP600984S, RSP601035S, RSP601038S, RSP600783S, RSP600912S, RSP600930S, RSP601015S, RSP601085S, RSP601112S, RSP601105S, RSP600988S, RSP600871S, RSP601089S, RSP600824S, RSP600100S, RSP600155S, RSP600517S, RSP600627S, RSP600845S, RSP600523S, RSP600639S, RSP600861S, RSP600654S, RSP600575S, RSP600521S, RSP600609S, RSP600614S, RSP600640S, RSP600650S, RSP600742S, RSP600616S, RSP600513S, RSP600151S, RSP600641S, RSP600649S, RSP600850S, RSP600860S, RSP600651S, RSP600520S, RSP600618S, RSP600837S, RSP600794S, RSP600179S, RSP600594S, RSP600741S, RSP600524S, RSP600648S, RSP600143S, RSP600753S, RSP600056S, RSP600061S, RSP600064S, RSP600171S, RSP600172S, RSP600543S, RSP600554S, RSP600587S, RSP600633S, RSP600634S, RSP600652S, RSP600766S, RSP600789S, RSP600799S, RSP600811S, RSP600823S, RSP600836S, RSP600839S, RSP600841S, RSP600859S, RSP601013S, RSP601016S, RSP601064S, RSP601076S, RSP601093S, RSP601094S, RSP600876S, RSP600882S, RSP600653S, RSP600516S, RSP600877S, RSP600878S, RSP601101S, RSP601102S, RSP600842S, RSP600602S, RSP600727S, RSP600615S, RSP600561S, RSP600579S, RSP600027S, RSP600563S, RSP600591S, RSP600855S, RSP600041S, RSP600872S, RSP600034S, RSP600536S, RSP600595S, RSP600596S, RSP600538S, RSP600559S, RSP600724S, RSP600564S, RSP600508S, RSP600510S, RSP600511S, RSP600519S, RSP600522S, RSP600525S, RSP600526S, RSP600552S, RSP600662S, RSP600752S, RSP600760S, RSP600795S, RSP600816S, RSP600924S, RSP600515S, RSP600528S, RSP600747S, RSP600785S, RSP600786S, RSP600788S, RSP600790S, RSP600642S, RSP600643S, RSP600644S, RSP600693S, RSP600776S, RSP600621S, RSP600622S, RSP600623S, RSP600624S, RSP600625S, RSP600657S, RSP600695S, RSP600704S, RSP600744S, RSP600784S, RSP600797S, RSP600818S, RSP600819S, RSP600910S, RSP600547S, RSP600553S, RSP600555S, RSP600556S, RSP600557S, RSP600588S, RSP600592S, RSP600626S, RSP600655S, RSP600676S, RSP600685S, RSP600687S, RSP600688S, RSP600746S, RSP600822S, RSP600826S, RSP600827S, RSP600931S, RSP600414S, RSP600755S, RSP600542S, RSP600645S, RSP600659S, RSP600664S, RSP600665S, RSP600666S, RSP600667S, RSP600668S, RSP600669S, RSP600678S, RSP600698S, RSP600702S, RSP600769S, RSP600778S, RSP600779S, RSP600820S, RSP600829S, RSP600832S, RSP600880S, RSP600881S, RSP600888S, RSP600914S, RSP600915S, RSP600918S, RSP600934S, RSP600967S, RSP600968S, RSP601004S, RSP601005S, RSP601010S, RSP601017S, RSP601027S, RSP601029S, RSP600919S, RSP600975S, RSP600983S, RSP601058S, RSP600838S, RSP600165S, RSP600401S, RSP600590S, RSP600777S, RSP601100S, RSP600927S, RSP600593S, RSP600077S, RSP600767S, RSP600774S, RSP600909S, RSP600887S, RSP600537S, RSP600540S, RSP600125S, RSP600617S, RSP600852S, RSP600512S, RSP600531S, RSP600549S, RSP600574S, RSP600546S, RSP600606S, RSP600607S, RSP600610S, RSP600612S, RSP600613S, RSP600656S, RSP600658S, RSP600660S, RSP600663S, RSP600671S, RSP600672S, RSP600673S, RSP600674S, RSP600675S, RSP600679S, RSP600680S, RSP600681S, RSP600682S, RSP600683S, RSP600686S, RSP600696S, RSP600697S, RSP600699S, RSP600701S, RSP600771S, RSP600772S, RSP600791S, RSP600803S, RSP600804S, RSP600805S, RSP600806S, RSP600809S, RSP600810S, RSP600812S, RSP600825S, RSP600830S, RSP600886S, RSP600890S, RSP600906S, RSP601025S, RSP601059S, RSP600605S, RSP600597S, RSP600598S, RSP600599S, RSP600600S, RSP600601S, RSP600603S, RSP600604S, RSP600620S, RSP600661S, RSP600677S, RSP600690S, RSP600692S, RSP600703S, RSP600754S, RSP600802S, RSP600821S, RSP600884S, RSP600889S, RSP600897S, RSP600898S, RSP600913S, RSP600935S, RSP600985S, RSP600864S, RSP600865S, RSP600866S, RSP600560S, RSP600843S, RSP600670S, RSP600807S, RSP600920S, RSP600735S, RSP600743S, RSP600750S, RSP600757S, RSP600765S, RSP600775S, RSP600782S, RSP600793S, RSP600831S, RSP600833S, RSP600834S, RSP600846S, RSP600851S, RSP600856S, RSP600863S, RSP600867S, RSP600868S, RSP600879S, RSP600883S, RSP600885S, RSP600891S, RSP600892S, RSP600893S, RSP600894S, RSP600895S, RSP600896S, RSP600899S, RSP600900S, RSP600901S, RSP600907S, RSP600916S, RSP600917S, RSP600921S, RSP600923S, RSP600925S, RSP600926S, RSP600928S, RSP600929S, RSP600974S, RSP600977S, RSP600978S, RSP600981S, RSP600982S, RSP600986S, RSP600989S, RSP600990S, RSP600991S, RSP601002S, RSP601003S, RSP601011S, RSP601012S, RSP601014S, RSP601020S, RSP601023S, RSP601024S, RSP601028S, RSP601030S, RSP601034S, RSP601037S, RSP601040S, RSP601045S, RSP601046S, RSP601047S, RSP601056S, RSP601067S, RSP601069S, RSP601086S, RSP601098S, RSP601104S, RSP601106S, RSP601107S, RSP600684S, RSP601113S, RSP601114S, RSP600980S, RSP601096S. 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-1727-2023&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-1727-2023&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-1727-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1727-2023 as Class I", "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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-1727-2023&lang=eng", "value": "Class I", "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-1727-2023&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-1727-2023/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. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "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." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1727-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1727-2023", "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 I", "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": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2023-05-10", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "GTIN 00763000178413, Lot Serial Numbers: RSP600249S, RSP600057S, RSP600253S, RSP600085S, RSP600014S, RSP600150S, RSP600148S, RSP600089S, RSP600091S, RSP600114S, RSP600189S, RSP600210S, RSP600394S, RSP600130S, RSP600216S, RSP600256S, RSP600386S, RSP600149S, RSP600245S, RSP600066S, RSP600068S, RSP600069S, RSP600083S, RSP600112S, RSP600132S, RSP600136S, RSP600404S, RSP600076S, RSP600731S, RSP600954S, RSP600955S, RSP600953S, RSP600070S, RSP600145S, RSP600157S, RSP600200S, RSP600226S, RSP600082S, RSP600139S, RSP600141S, RSP600152S, RSP600163S, RSP600074S, RSP600732S, RSP600204S, RSP600369S, RSP600726S, RSP600748S, RSP600048S, RSP600080S, RSP600363S, RSP600396S, RSP600397S, RSP600408S, RSP600444S, RSP600544S, RSP600335S, RSP600383S, RSP600400S, RSP600808S, RSP600862S, RSP600939S, RSP600949S, RSP600950S, RSP600218S, RSP600288S, RSP600246S, RSP600193S, RSP600395S, RSP600725S, RSP600360S, RSP600413S, RSP600202S, RSP600736S, RSP600138S, RSP600049S, RSP600065S, RSP600095S, RSP600346S, RSP600372S, RSP600059S, RSP600219S, RSP600079S, RSP600190S, RSP600398S, RSP600217S, RSP600230S, RSP600723S, RSP600203S, RSP600221S, RSP600187S, RSP600250S, RSP600276S, RSP600060S, RSP600267S, RSP600392S, RSP600813S, RSP600154S, RSP600209S, RSP600211S, RSP600224S, RSP600729S, RSP600758S, RSP600134S, RSP600096S, RSP600734S, RSP600273S, RSP600722S, RSP600945S, RSP600946S; 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