{ "@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-1785-2023.jsonld", "@type": "schema:Dataset", "name": "CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators", "description": "FDA recall Z-1785-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; 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-1785-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; 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-1785-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1785-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators", "text": "The FDA logged enforcement record Z-1785-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; 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 00763000178307, Lot Serial numbers: RTX600076S, RTX600084S, RTX600139S, RTX600148S, RTX600114S, RTX600308S, RTX600386S, RTX600327S, RTX600334S, RTX600372S, RTX600046S, RTX600048S, RTX600066S, RTX600108S, RTX600261S, RTX600345S, RTX600586S, RTX600382S, RTX600388S, RTX600064S, RTX600069S, RTX600096S, RTX600377S, RTX600360S, RTX600581S, RTX600158S, RTX600306S, RTX600713S, RTX600100S, RTX600319S, RTX600594S, RTX600720S, RTX600727S, RTX600045S, RTX600153S, RTX600157S, RTX600326S, RTX600081S, RTX600146S, RTX600055S, RTX600058S, RTX600143S, RTX600314S, RTX600323S, RTX600332S, RTX600344S, RTX600693S, RTX600307S, RTX600310S, RTX600317S, RTX600588S, RTX600705S, RTX600072S, RTX600095S, RTX600147S, RTX600695S, RTX600698S, RTX600309S, RTX600792S, RTX600167S, RTX600807S, RTX600387S, RTX600086S, RTX600322S, RTX600343S, RTX600365S, RTX600091S, RTX600124S, RTX600597S, RTX600688S, RTX600689S, RTX600799S, RTX600800S, RTX600085S, RTX600087S, RTX600312S, RTX600019S, RTX600120S, RTX600137S, RTX600260S, RTX600370S, RTX600391S, RTX600724S, RTX600149S, RTX600596S, RTX600159S, RTX600700S, RTX600692S, RTX600170S, RTX600697S, RTX600587S, RTX600330S, RTX600256S, RTX600369S, RTX600394S, RTX600398S, RTX600591S, RTX600592S, RTX600690S, RTX600350S, RTX600363S, RTX600589S, RTX600257S, RTX600276S, RTX600277S, RTX600321S, RTX600346S, RTX600354S, RTX600356S, RTX600402S, RTX600481S, RTX600065S, RTX600205S, RTX600210S, RTX600264S, RTX600348S, RTX600351S, RTX600732S, RTX600735S, RTX600743S, RTX600746S, RTX600750S, RTX600752S, RTX600757S, RTX600758S, RTX600760S, RTX600761S, RTX600788S, RTX600789S, RTX600790S, RTX600791S, RTX600795S, RTX600797S, RTX600798S, RTX600070S, RTX600336S, RTX600338S, RTX600339S, RTX600811S, RTX600116S, RTX600401S, RTX600706S, RTX600590S, RTX600201S, RTX600374S, RTX600112S, RTX600584S, RTX600320S, RTX600106S, RTX600121S, RTX600583S, RTX600047S, RTX600331S, RTX600341S, RTX600342S, RTX600349S, RTX600358S, RTX600371S, RTX600376S, RTX600380S, RTX600389S, RTX600392S, RTX600393S, RTX600395S, RTX600396S, RTX600585S, RTX600595S, RTX600053S, RTX600077S, RTX600080S, RTX600082S, RTX600335S, RTX600340S, RTX600381S, RTX600580S, RTX600131S, RTX600694S, RTX600054S, RTX600726S, RTX600305S, RTX600329S, RTX600169S, RTX600399S, RTX600400S, RTX600582S, RTX600050S, RTX600063S, RTX600051S, RTX600075S, RTX600385S, RTX600117S, RTX600717S, RTX600782S, RTX600801S, RTX600802S; GTIN 00763000178321, Lot Serial Numbers: RTX600495S, RTX600869S, RTX600878S, RTX600868S, RTX600848S, RTX600890S, RTX600844S, RTX600472S, RTX600624S, RTX600628S, RTX600629S, RTX600630S, RTX600730S, RTX600773S, RTX600832S, RTX600836S, RTX600989S, RTX600850S, RTX600978S, RTX600625S, RTX600840S, RTX600574S, RTX600845S, RTX600977S, RTX600834S, RTX600900S, RTX600508S, RTX600564S, RTX600967S, RTX600745S, RTX600896S, RTX600626S, RTX600517S, RTX600827S, RTX600603S, RTX600490S, RTX600621S, RTX600863S, RTX600941S, RTX600887S, RTX600936S, RTX600468S, RTX600469S, RTX600477S, RTX600478S, RTX600491S, RTX600554S, RTX600604S, RTX600607S, RTX600620S, RTX600631S, RTX600829S, RTX600854S, RTX600163S, RTX600249S, RTX600492S, RTX600973S, RTX600088S, RTX600179S, RTX600269S, RTX600826S, RTX600913S, RTX600463S, RTX600870S, RTX600514S, RTX600515S, RTX600710S, RTX600928S, RTX600912S, RTX600609S, RTX600467S, RTX600474S, RTX600825S, RTX600828S, RTX600830S, RTX600982S, RTX600015S, RTX600286S, RTX600539S, RTX600897S, RTX600852S, RTX600611S, RTX600859S, RTX600888S, RTX600907S, RTX600466S, RTX600470S, RTX600536S, RTX600569S, RTX600576S, RTX600578S, RTX600833S, RTX600268S, RTX600034S, RTX600546S, RTX600558S, RTX600516S, RTX600747S, RTX600748S, RTX600835S, RTX600847S, RTX600849S, RTX600985S, RTX600986S, RTX600533S, RTX600566S, RTX600571S, RTX600881S, RTX600464S, RTX600857S, RTX600861S, RTX600243S, RTX600851S, RTX600614S, RTX600876S, RTX600547S, RTX600856S, RTX600885S, RTX600540S, RTX600610S, RTX600842S, RTX600627S, RTX600632S, RTX600556S, RTX600606S, RTX600766S, RTX600951S, RTX600988S, RTX600937S, RTX600935S, RTX600537S, RTX600780S, RTX600803S, RTX600831S, RTX600874S, RTX600940S, RTX600981S, RTX600617S, RTX600622S, RTX600846S, RTX600995S, RTX600703S, RTX600028S, RTX600022S, RTX600579S, RTX600027S, RTX600530S, RTX600483S, RTX600615S, RTX600482S, RTX600014S, RTX600980S, RTX600575S, RTX600619S, RTX600485S, RTX600487S, RTX600494S, RTX600521S, RTX600853S, RTX600018S, RTX600231S, RTX600247S, RTX600262S, RTX600475S, RTX600493S, RTX600518S, RTX600550S, RTX600612S, RTX600858S, RTX600923S, RTX600731S, RTX600768S, RTX600769S, RTX600772S, RTX600775S, RTX600776S, RTX600505S, RTX600538S, RTX600542S, RTX600605S, RTX600548S, RTX600557S, RTX600560S, RTX600567S, RTX600568S, RTX600570S, RTX600602S, RTX600635S, RTX600637S, RTX600696S, RTX600708S, RTX600738S, RTX600742S, RTX601003S, RTX600532S, RTX600535S, RTX600598S, RTX600718S, RTX600725S, RTX600202S, RTX600476S, RTX600555S, RTX600258S, RTX600252S, RTX600251S, RTX600016S, RTX600486S, RTX600029S, RTX600035S, RTX601005S, RTX600278S, RTX600471S, RTX600577S, RTX600506S, RTX600507S, RTX600509S, RTX600510S, RTX600511S, RTX600512S, RTX600549S, RTX600704S, RTX600711S, RTX600716S, RTX600025S, RTX600030S, RTX600502S, RTX600503S, RTX600543S, RTX600544S, RTX600559S, RTX600561S, RTX600572S, RTX600573S, RTX600599S, RTX600634S, RTX600709S, RTX600719S, RTX600734S, RTX600736S, RTX600970S, RTX600498S, RTX600701S, RTX600733S, RTX600737S, RTX600739S, RTX600740S, RTX600741S, RTX600744S, RTX600774S, RTX600839S, RTX600875S, RTX600892S, RTX600895S, RTX600901S, RTX600968S, RTX600987S, RTX600996S, RTX601000S, RTX601004S, RTX601015S, RTX601018S, RTX601020S, RTX600600S, RTX600608S, RTX600749S, RTX600867S, RTX600984S. 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-1785-2023&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-1785-2023&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-1785-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1785-2023 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-1785-2023&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-1785-2023&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-1785-2023/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-1785-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1785-2023", "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 00763000178307, Lot Serial numbers: RTX600076S, RTX600084S, RTX600139S, RTX600148S, RTX600114S, RTX600308S, RTX600386S, RTX600327S, RTX600334S, RTX600372S, RTX600046S, RTX600048S, RTX600066S, RTX600108S, RTX600261S, RTX600345S, RTX600586S, RTX600382S, RTX600388S, RTX600064S, RTX600069S, RTX600096S, RTX600377S, RTX600360S, RTX600581S, RTX600158S, RTX600306S, RTX600713S, RTX600100S, RTX600319S, RTX600594S, RTX600720S, RTX600727S, RTX600045S, RTX600153S, RTX600157S, RTX600326S, RTX600081S, RTX600146S, RTX600055S, RTX600058S, RTX600143S, RTX600314S, RTX600323S, RTX600332S, RTX600344S, RTX600693S, RTX600307S, RTX600310S, RTX600317S, RTX600588S, RTX600705S, RTX600072S, RTX600095S, RTX600147S, RTX600695S, RTX600698S, RTX600309S, RTX600792S, RTX600167S, RTX600807S, RTX600387S, RTX600086S, RTX600322S, RTX600343S, RTX600365S, RTX600091S, RTX600124S, RTX600597S, RTX600688S, RTX600689S, RTX600799S, RTX600800S, RTX600085S, RTX600087S, RTX600312S, RTX600019S, RTX600120S, RTX600137S, RTX600260S, RTX600370S, RTX600391S, RTX600724S, RTX600149S, RTX600596S, RTX600159S, RTX600700S, RTX600692S, RTX600170S, RTX600697S, RTX600587S, RTX600330S, RTX600256S, RTX600369S, RTX600394S, RTX600398S, RTX600591S, RTX600592S, RTX600690S, RTX600350S, RTX600363S, RTX600589S, RTX600257S, RTX600276S, RTX600277S, RTX600321S, RTX600346S, RTX600354S, RTX600356S, RTX600402S, RTX600481S, RTX600065S, RTX600205S, RTX600210S, RTX600264S, RTX600348S, RTX600351S, RTX600732S, RTX600735S, RTX600743S, RTX600746S, RTX600750S, RTX600752S, RTX600757S, RTX600758S, RTX600760S, RTX600761S, RTX600788S, RTX600789S, RTX600790S, RTX600791S, RTX600795S, RTX600797S, RTX600798S, RTX600070S, RTX600336S, RTX600338S, RTX600339S, RTX600811S, RTX600116S, RTX600401S, RTX600706S, RTX600590S, RTX600201S, RTX600374S, RTX600112S, RTX600584S, RTX600320S, RTX600106S, RTX600121S, RTX600583S, RTX600047S, RTX600331S, RTX600341S, RTX600342S, RTX600349S, RTX600358S, RTX600371S, RTX600376S, RTX600380S, RTX600389S, RTX600392S, RTX600393S, RTX600395S, RTX600396S, RTX600585S, RTX600595S, RTX600053S, RTX600077S, RTX600080S, RTX600082S, RTX600335S, RTX600340S, RTX600381S, RTX600580S, RTX600131S, RTX600694S, RTX600054S, RTX600726S, RTX600305S, RTX600329S, RTX600169S, RTX600399S, RTX600400S, RTX600582S, RTX600050S, RTX600063S, RTX600051S, RTX600075S, RTX600385S, RTX600117S, RTX600717S, RTX600782S, RTX600801S, RTX600802S; 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