{ "@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-1786-2023.jsonld", "@type": "schema:Dataset", "name": "CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators", "description": "FDA recall Z-1786-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; 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-1786-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; 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-1786-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1786-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators", "text": "The FDA logged enforcement record Z-1786-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; 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 00763000178291, Lot Serial numbers: RTW600585S, RTW600307S, RTW600091S, RTW600313S, RTW600121S, RTW600342S, RTW600596S, RTW600074S, RTW600144S, RTW600102S, RTW600319S, RTW600578S, RTW600346S, RTW600277S, RTW600309S, RTW600581S, RTW600098S, RTW600118S, RTW600119S, RTW600123S, RTW600133S, RTW600138S, RTW600159S, RTW600168S, RTW600205S, RTW600052S, RTW600067S, RTW600217S, RTW600333S, RTW600592S, RTW600059S, RTW600151S, RTW600169S, RTW600196S, RTW600229S, RTW600304S, RTW600306S, RTW600223S, RTW600062S, RTW600171S, RTW600049S, RTW600057S, RTW600126S, RTW600130S, RTW600153S, RTW600158S, RTW600163S, RTW600181S, RTW600182S, RTW600188S, RTW600204S, RTW600211S, RTW600230S, RTW600240S, RTW600245S, RTW600247S, RTW600249S, RTW600250S, RTW600317S, RTW600323S, RTW600338S, RTW600588S, RTW600589S, RTW600593S, RTW600339S, RTW600819S, RTW600113S, RTW600594S, RTW600120S, RTW600244S, RTW600008S, RTW600056S, RTW600089S, RTW600183S, RTW600239S, RTW600292S, RTW600297S, RTW600069S, RTW600148S, RTW600080S, RTW600156S, RTW600179S, RTW600094S, RTW600127S, RTW600161S, RTW600813S, RTW600068S, RTW600110S, RTW600149S, RTW600237S, RTW600345S, RTW600591S, RTW600082S, RTW600087S, RTW600090S, RTW600350S, RTW600358S, RTW600362S, RTW600363S, RTW600365S, RTW600054S, RTW600075S, RTW600347S, RTW600619S, RTW600620S, RTW600624S, RTW600625S, RTW600628S, RTW600630S, RTW600634S, RTW600637S, RTW600640S, RTW600641S, RTW600643S, RTW600648S, RTW600649S, RTW600650S, RTW600651S, RTW600654S, RTW600655S, RTW600658S, RTW600662S, RTW600663S, RTW600664S, RTW600670S, RTW600672S, RTW600673S, RTW600743S, RTW600758S, RTW600759S, RTW600777S, RTW600818S, RTW600820S, RTW600330S, RTW600331S, RTW600125S, RTW600160S, RTW600053S, RTW600595S, RTW600065S, RTW600109S, RTW600136S, RTW600147S, RTW600200S, RTW600308S, RTW600085S, RTW600175S, RTW600228S, RTW600332S, RTW600073S, RTW600172S, RTW600315S, RTW600143S, RTW600165S, RTW600187S, RTW600213S, RTW600584S, RTW600048S, RTW600164S, RTW600586S, RTW600097S, RTW600129S, RTW600195S, RTW600254S, RTW600114S, RTW600343S, RTW600101S, RTW600116S, RTW600104S, RTW600811S, RTW600812S; GTIN 00763000178314, Lot Serial Numbers: RTW600542S, RTW600770S, RTW600943S, RTW600680S, RTW600805S, RTW600918S, RTW600611S, RTW600681S, RTW600688S, RTW600782S, RTW600635S, RTW600614S, RTW600653S, RTW600913S, RTW600484S, RTW600716S, RTW600405S, RTW600413S, RTW600721S, RTW600804S, RTW600744S, RTW600404S, RTW600496S, RTW600535S, RTW600505S, RTW600774S, RTW600888S, RTW600494S, RTW600526S, RTW600557S, RTW600335S, RTW600497S, RTW600521S, RTW600882S, RTW600486S, RTW600540S, RTW600603S, RTW600407S, RTW600500S, RTW600522S, RTW600608S, RTW600797S, RTW600038S, RTW600321S, RTW600410S, RTW600510S, RTW600397S, RTW600852S, RTW600536S, RTW600684S, RTW600691S, RTW600740S, RTW600545S, RTW600550S, RTW600742S, RTW600750S, RTW600441S, RTW600731S, RTW600493S, RTW600415S, RTW600492S, RTW600607S, RTW600671S, RTW600456S, RTW600686S, RTW600687S, RTW600718S, RTW600934S, RTW600512S, RTW600604S, RTW600714S, RTW600666S, RTW600705S, RTW600775S, RTW600022S, RTW600316S, RTW600340S, RTW600465S, RTW600720S, RTW600412S, RTW600753S, RTW600538S, RTW600702S, RTW600537S, RTW600555S, RTW600703S, RTW600707S, RTW600393S, RTW600549S, RTW600623S, RTW600318S, RTW600336S, RTW600388S, RTW600469S, RTW600334S, RTW600669S, RTW600856S, RTW600899S, RTW600631S, RTW600908S, RTW600909S, RTW600470S, RTW600488S, RTW600509S, RTW600539S, RTW600615S, RTW600642S, RTW600715S, RTW600552S, RTW600661S, RTW600728S, RTW600767S, RTW600636S, RTW600487S, RTW600516S, RTW600502S, RTW600848S, RTW600749S, RTW600554S, RTW600408S, RTW600495S, RTW600517S, RTW600689S, RTW600660S, RTW600723S, RTW600769S, RTW600838S, RTW600906S, RTW600543S, RTW600561S, RTW600692S, RTW600746S, RTW600466S, RTW600467S, RTW600553S, RTW600647S, RTW600490S, RTW600232S, RTW600392S, RTW600395S, RTW600513S, RTW600032S, RTW600361S, RTW600421S, RTW600433S, RTW600436S, RTW600828S, RTW600400S, RTW600518S, RTW600645S, RTW600695S, RTW600341S, RTW600387S, RTW600419S, RTW600394S, RTW600461S, RTW600463S, RTW600514S, RTW600755S, RTW600364S, RTW600389S, RTW600398S, RTW600399S, RTW600403S, RTW600417S, RTW600420S, RTW600427S, RTW600428S, RTW600489S, RTW600508S, RTW600519S, RTW600523S, RTW600529S, RTW600530S, RTW600626S, RTW600694S, RTW600698S, RTW600712S, RTW600727S, RTW600748S, RTW600778S, RTW600781S, RTW600889S, RTW600911S, RTW600515S, RTW600697S, RTW600713S, RTW600847S, RTW600040S, RTW600041S, RTW600045S, RTW600324S, RTW600344S, RTW600422S, RTW600474S, RTW600478S, RTW600479S, RTW600480S, RTW600507S, RTW600527S, RTW600679S, RTW600690S, RTW600784S, RTW600832S, RTW600600S, RTW600601S, RTW600602S, RTW600605S, RTW600610S, RTW600617S, RTW600618S, RTW600453S, RTW600454S, RTW600425S, RTW600426S, RTW600459S, RTW600511S, RTW600524S, RTW600528S, RTW600531S, RTW600534S, RTW600582S, RTW600597S, RTW600450S, RTW600580S, RTW600613S, RTW600020S, RTW600498S, RTW600556S, RTW600471S, RTW600883S, RTW600034S, RTW600359S, RTW600360S, RTW600018S, RTW600396S, RTW600559S, RTW600752S, RTW600783S, RTW600033S, RTW600668S, RTW600754S, RTW600025S, RTW600546S, RTW600710S, RTW600730S, RTW600765S, RTW600351S, RTW600547S, RTW600677S, RTW600700S, RTW600806S, RTW600855S, RTW600444S, RTW600445S, RTW600504S, RTW600027S, RTW600028S, RTW600029S, RTW600356S, RTW600390S, RTW600476S, RTW600430S, RTW600739S, RTW600795S, RTW600482S, RTW600598S, RTW600616S, RTW600685S, RTW600693S, RTW600704S, RTW600737S, RTW600745S, RTW600766S, RTW600771S, RTW600780S, RTW600792S, RTW600799S, RTW600839S, RTW600850S, RTW600859S, RTW600865S, RTW600866S, RTW600885S, RTW600891S, RTW600893S, RTW600904S, RTW600912S, RTW600929S, RTW600932S, RTW600933S, RTW600937S, RTW600954S, RTW600966S, RTW601008S, RTW600533S, RTW600541S, RTW600544S, RTW600587S, RTW600599S, RTW600786S, RTW600791S, RTW600854S, RTW600894S, RTW600921S. 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-1786-2023&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-1786-2023&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-1786-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1786-2023 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-1786-2023&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-1786-2023&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-1786-2023/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-1786-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1786-2023", "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 00763000178291, Lot Serial numbers: RTW600585S, RTW600307S, RTW600091S, RTW600313S, RTW600121S, RTW600342S, RTW600596S, RTW600074S, RTW600144S, RTW600102S, RTW600319S, RTW600578S, RTW600346S, RTW600277S, RTW600309S, RTW600581S, RTW600098S, RTW600118S, RTW600119S, RTW600123S, RTW600133S, RTW600138S, RTW600159S, RTW600168S, RTW600205S, RTW600052S, RTW600067S, RTW600217S, RTW600333S, RTW600592S, RTW600059S, RTW600151S, RTW600169S, RTW600196S, RTW600229S, RTW600304S, RTW600306S, RTW600223S, RTW600062S, RTW600171S, RTW600049S, RTW600057S, RTW600126S, RTW600130S, RTW600153S, RTW600158S, RTW600163S, RTW600181S, RTW600182S, RTW600188S, RTW600204S, RTW600211S, RTW600230S, RTW600240S, RTW600245S, RTW600247S, RTW600249S, RTW600250S, RTW600317S, RTW600323S, RTW600338S, RTW600588S, RTW600589S, RTW600593S, RTW600339S, RTW600819S, RTW600113S, RTW600594S, RTW600120S, RTW600244S, RTW600008S, RTW600056S, RTW600089S, RTW600183S, RTW600239S, RTW600292S, RTW600297S, RTW600069S, RTW600148S, RTW600080S, RTW600156S, RTW600179S, RTW600094S, RTW600127S, RTW600161S, RTW600813S, RTW600068S, RTW600110S, RTW600149S, RTW600237S, RTW600345S, RTW600591S, RTW600082S, RTW600087S, RTW600090S, RTW600350S, RTW600358S, RTW600362S, RTW600363S, RTW600365S, RTW600054S, RTW600075S, RTW600347S, RTW600619S, RTW600620S, RTW600624S, RTW600625S, RTW600628S, RTW600630S, RTW600634S, RTW600637S, RTW600640S, RTW600641S, RTW600643S, RTW600648S, RTW600649S, RTW600650S, RTW600651S, RTW600654S, RTW600655S, RTW600658S, RTW600662S, RTW600663S, RTW600664S, RTW600670S, RTW600672S, RTW600673S, RTW600743S, RTW600758S, RTW600759S, RTW600777S, RTW600818S, RTW600820S, RTW600330S, RTW600331S, RTW600125S, RTW600160S, RTW600053S, RTW600595S, RTW600065S, RTW600109S, RTW600136S, RTW600147S, RTW600200S, RTW600308S, RTW600085S, RTW600175S, RTW600228S, RTW600332S, RTW600073S, RTW600172S, RTW600315S, RTW600143S, RTW600165S, RTW600187S, RTW600213S, RTW600584S, RTW600048S, RTW600164S, RTW600586S, RTW600097S, RTW600129S, RTW600195S, RTW600254S, RTW600114S, RTW600343S, RTW600101S, RTW600116S, RTW600104S, RTW600811S, RTW600812S; 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