{ "@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-1787-2023.jsonld", "@type": "schema:Dataset", "name": "CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators", "description": "FDA recall Z-1787-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; 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-1787-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; 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-1787-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1787-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators", "text": "The FDA logged enforcement record Z-1787-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; 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 00763000178260, Lot Serial Numbers: RTT600077S, RTT600166S, RTT600169S, RTT600064S, RTT600083S, RTT600071S, RTT600042S, RTT600028S, RTT600107S, RTT600034S, RTT600421S, RTT600432S, RTT600434S, RTT600574S, RTT600161S, RTT600054S, RTT600160S, RTT600231S, RTT600431S, RTT600045S, RTT600165S, RTT600022S, RTT600062S, RTT600091S, RTT600195S, RTT600430S, RTT600437S, RTT600438S, RTT600125S, RTT600533S, RTT600427S, RTT600481S, RTT600111S, RTT600128S, RTT600040S, RTT600066S, RTT600046S, RTT600573S, RTT600322S, RTT600076S, RTT600024S, RTT600134S, RTT600150S, RTT600531S, RTT600047S, RTT600086S, RTT600220S, RTT600059S, RTT600063S, RTT600426S, RTT600530S, RTT600075S, RTT600095S, RTT600149S, RTT600537S, RTT600541S, RTT600546S, RTT600549S, RTT600550S, RTT600552S, RTT600716S, RTT600889S, RTT600093S, RTT600057S, RTT600156S, RTT600157S, RTT600037S, RTT600429S, RTT600236S, RTT600422S, RTT600436S, RTT600143S, RTT600507S, RTT600065S, RTT600072S, RTT600435S, RTT600056S, RTT600073S, RTT600098S, RTT600067S, RTT600425S, RTT600081S, RTT600035S, RTT600527S, RTT600087S, RTT600433S, RTT600140S, RTT600167S, RTT600168S, RTT600089S, RTT600103S, RTT600030S, RTT600061S, RTT600420S, RTT600566S, RTT600567S; GTIN 00763000178284, Lot Serial Numbers: RTT600985S, RTT600411S, RTT600879S, RTT600925S, RTT601085S, RTT600918S, RTT600632S, RTT600977S, RTT600367S, RTT600456S, RTT600459S, RTT600389S, RTT600323S, RTT600351S, RTT600453S, RTT600356S, RTT600360S, RTT600377S, RTT600558S, RTT600577S, RTT600547S, RTT600314S, RTT600334S, RTT600522S, RTT600592S, RTT600608S, RTT600609S, RTT600601S, RTT600630S, RTT600631S, RTT600663S, RTT600668S, RTT600669S, RTT600967S, RTT600521S, RTT600948S, RTT600968S, RTT600969S, RTT600315S, RTT600338S, RTT600512S, RTT600346S, RTT600350S, RTT600443S, RTT600482S, RTT600595S, RTT600606S, RTT600329S, RTT600375S, RTT600318S, RTT600310S, RTT600133S, RTT600397S, RTT600518S, RTT600898S, RTT600307S, RTT600414S, RTT600452S, RTT600548S, RTT600587S, RTT600942S, RTT600956S, RTT600962S, RTT600490S, RTT600525S, RTT600536S, RTT600316S, RTT600354S, RTT600361S, RTT600517S, RTT600596S, RTT600640S, RTT600010S, RTT600015S, RTT600016S, RTT600017S, RTT600135S, RTT600142S, RTT600148S, RTT600204S, RTT600330S, RTT600331S, RTT600335S, RTT600342S, RTT600343S, RTT600344S, RTT600440S, RTT600441S, RTT600450S, RTT600454S, RTT600455S, RTT600528S, RTT600551S, RTT600553S, RTT600575S, RTT600646S, RTT600648S, RTT600649S, RTT600958S, RTT600652S, RTT600023S, RTT600964S, RTT600379S, RTT600396S, RTT600617S, RTT600624S, RTT600578S, RTT600457S, RTT600458S, RTT600586S, RTT600498S, RTT600341S, RTT600347S, RTT600381S, RTT600399S, RTT600582S, RTT600583S, RTT600506S, RTT600215S, RTT600308S, RTT600326S, RTT600327S, RTT600368S, RTT600370S, RTT600390S, RTT600580S, RTT600651S, RTT600304S, RTT600359S, RTT600488S, RTT600376S, RTT600378S, RTT600380S, RTT600418S, RTT600419S, RTT600495S, RTT600653S, RTT600661S, RTT600664S, RTT600903S, RTT600904S, RTT600913S, RTT600916S, RTT600929S, RTT600391S, RTT600392S, RTT600406S, RTT600409S, RTT600500S, RTT600503S, RTT600504S, RTT600878S, RTT600910S, RTT600365S, RTT600369S, RTT600371S, RTT600372S, RTT600373S, RTT600374S, RTT600408S, RTT600410S, RTT600412S, RTT600415S, RTT600483S, RTT600485S, RTT600494S, RTT600499S, RTT600529S, RTT600532S, RTT600544S, RTT600563S, RTT600634S, RTT600635S, RTT600636S, RTT600645S, RTT600647S, RTT600885S, RTT600900S, RTT600905S, RTT600667S, RTT600883S, RTT600305S, RTT600451S, RTT600337S, RTT600196S, RTT600309S, RTT600348S, RTT600353S, RTT600355S, RTT600357S, RTT600358S, RTT600382S, RTT600386S, RTT600387S, RTT600388S, RTT600393S, RTT600400S, RTT600401S, RTT600402S, RTT600403S, RTT600404S, RTT600405S, RTT600413S, RTT600416S, RTT600417S, RTT600477S, RTT600478S, RTT600479S, RTT600484S, RTT600487S, RTT600491S, RTT600492S, RTT600493S, RTT600497S, RTT600505S, RTT600509S, RTT600523S, RTT600524S, RTT600534S, RTT600535S, RTT600554S, RTT600556S, RTT600597S, RTT600626S, RTT600627S, RTT600629S, RTT600633S, RTT600637S, RTT600642S, RTT600644S, RTT600656S, RTT600660S, RTT600882S, RTT600884S, RTT600891S, RTT600894S, RTT600896S, RTT600897S, RTT600901S, RTT600908S, RTT600911S, RTT600935S, RTT600345S, RTT600363S, RTT600394S, RTT600398S, RTT600407S, RTT600540S, RTT600559S, RTT600568S, RTT600665S, RTT600666S, RTT600887S, RTT600890S, RTT600906S, RTT600907S, RTT600912S, RTT600983S, RTT600319S, RTT600496S, RTT600579S, RTT600591S, RTT600604S, RTT600607S, RTT600610S, RTT600612S, RTT600613S, RTT600614S, RTT600625S, RTT600881S, RTT600886S, RTT600919S, RTT600920S, RTT600921S, RTT600928S, RTT600934S, RTT600936S, RTT600937S, RTT600939S, RTT600941S, RTT600944S, RTT600945S, RTT600946S, RTT600947S, RTT600957S, RTT600974S, RTT600984S, RTT600988S, RTT601082S, RTT601084S, RTT601086S, RTT601087S, RTT601093S, RTT601094S, RTT601095S, RTT601096S, RTT601098S, RTT601104S, RTT601105S, RTT601106S, RTT601108S, RTT601111S, RTT601127S, RTT600449S, RTT600979S, RTT600620S, RTT600718S, RTT601083S. 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-1787-2023&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-1787-2023&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-1787-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1787-2023 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-1787-2023&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-1787-2023&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-1787-2023/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-1787-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1787-2023", "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 00763000178260, Lot Serial Numbers: RTT600077S, RTT600166S, RTT600169S, RTT600064S, RTT600083S, RTT600071S, RTT600042S, RTT600028S, RTT600107S, RTT600034S, RTT600421S, RTT600432S, RTT600434S, RTT600574S, RTT600161S, RTT600054S, RTT600160S, RTT600231S, RTT600431S, RTT600045S, RTT600165S, RTT600022S, RTT600062S, RTT600091S, RTT600195S, RTT600430S, RTT600437S, RTT600438S, RTT600125S, RTT600533S, RTT600427S, RTT600481S, RTT600111S, RTT600128S, RTT600040S, RTT600066S, RTT600046S, RTT600573S, RTT600322S, RTT600076S, RTT600024S, RTT600134S, RTT600150S, RTT600531S, RTT600047S, RTT600086S, RTT600220S, RTT600059S, RTT600063S, RTT600426S, RTT600530S, RTT600075S, RTT600095S, RTT600149S, RTT600537S, RTT600541S, RTT600546S, RTT600549S, RTT600550S, RTT600552S, RTT600716S, RTT600889S, RTT600093S, RTT600057S, RTT600156S, RTT600157S, RTT600037S, RTT600429S, RTT600236S, RTT600422S, RTT600436S, RTT600143S, RTT600507S, RTT600065S, RTT600072S, RTT600435S, RTT600056S, RTT600073S, RTT600098S, RTT600067S, RTT600425S, RTT600081S, RTT600035S, RTT600527S, RTT600087S, RTT600433S, RTT600140S, RTT600167S, RTT600168S, RTT600089S, RTT600103S, RTT600030S, RTT600061S, RTT600420S, RTT600566S, RTT600567S; GTIN 00763000178284, Lot Serial Numbers: RTT600985S, RTT600411S, RTT600879S, RTT600925S, RTT601085S, RTT600918S, RTT600632S, RTT600977S, RTT600367S, RTT600456S, RTT600459S, RTT600389S, RTT600323S, RTT600351S, RTT600453S, RTT600356S, RTT600360S, RTT600377S, RTT600558S, RTT600577S, RTT600547S, RTT600314S, RTT600334S, RTT600522S, RTT600592S, RTT600608S, RTT600609S, RTT600601S, RTT600630S, RTT600631S, RTT600663S, RTT600668S, RTT600669S, RTT600967S, RTT600521S, RTT600948S, RTT600968S, RTT600969S, RTT600315S, RTT600338S, RTT600512S, RTT600346S, RTT600350S, RTT600443S, RTT600482S, RTT600595S, RTT600606S, RTT600329S, RTT600375S, RTT600318S, RTT600310S, RTT600133S, RTT600397S, RTT600518S, RTT600898S, RTT600307S, RTT600414S, RTT600452S, RTT600548S, RTT600587S, RTT600942S, RTT600956S, RTT600962S, RTT600490S, RTT600525S, RTT600536S, RTT600316S, RTT600354S, RTT600361S, RTT600517S, RTT600596S, RTT600640S, RTT600010S, RTT600015S, RTT600016S, RTT600017S, RTT600135S, RTT600142S, RTT600148S, RTT600204S, RTT600330S, RTT600331S, RTT600335S, RTT600342S, RTT600343S, RTT600344S, RTT600440S, RTT600441S, RTT600450S, RTT600454S, RTT600455S, RTT600528S, RTT600551S, RTT600553S, RTT600575S, RTT600646S, RTT600648S, RTT600649S, RTT600958S, RTT600652S, RTT600023S, RTT600964S, RTT600379S, RTT600396S, RTT600617S, RTT600624S, RTT600578S, RTT600457S, RTT600458S, RTT600586S, RTT600498S, RTT600341S, RTT600347S, RTT600381S, RTT600399S, RTT600582S, RTT600583S, RTT600506S, RTT600215S, RTT600308S, RTT600326S, RTT600327S, RTT600368S, RTT600370S, RTT600390S, RTT600580S, RTT600651S, RTT600304S, RTT600359S, RTT600488S, RTT600376S, RTT600378S, RTT600380S, RTT600418S, RTT600419S, RTT600495S, RTT600653S, RTT600661S, RTT600664S, RTT600903S, RTT600904S, RTT600913S, RTT600916S, RTT600929S, RTT600391S, RTT600392S, RTT600406S, RTT600409S, RTT600500S, RTT600503S, RTT600504S, RTT600878S, RTT600910S, RTT600365S, RTT600369S, RTT600371S, RTT600372S, RTT600373S, RTT600374S, RTT600408S, RTT600410S, RTT600412S, RTT600415S, RTT600483S, RTT600485S, RTT600494S, RTT600499S, RTT600529S, RTT600532S, RTT600544S, RTT600563S, RTT600634S, RTT600635S, RTT600636S, RTT600645S, RTT600647S, RTT600885S, RTT600900S, RTT600905S, RTT600667S, RTT600883S, RTT600305S, RTT600451S, RTT600337S, RTT600196S, RTT600309S, RTT600348S, RTT600353S, RTT600355S, RTT600357S, RTT600358S, RTT600382S, RTT600386S, RTT600387S, RTT600388S, RTT600393S, RTT600400S, RTT600401S, RTT600402S, RTT600403S, RTT600404S, RTT600405S, RTT600413S, RTT600416S, RTT600417S, RTT600477S, RTT600478S, RTT600479S, RTT600484S, RTT600487S, RTT600491S, RTT600492S, RTT600493S, RTT600497S, RTT600505S, RTT600509S, RTT600523S, RTT600524S, RTT600534S, RTT600535S, RTT600554S, RTT600556S, RTT600597S, RTT600626S, RTT600627S, RTT600629S, RTT600633S, RTT600637S, RTT600642S, RTT600644S, RTT600656S, RTT600660S, RTT600882S, RTT600884S, RTT600891S, RTT600894S, RTT600896S, RTT600897S, RTT600901S, RTT600908S, RTT600911S, RTT600935S, RTT600345S, RTT600363S, RTT600394S, RTT600398S, RTT600407S, RTT600540S, RTT600559S, RTT600568S, RTT600665S, RTT600666S, RTT600887S, RTT600890S, RTT600906S, RTT600907S, RTT600912S, RTT600983S, RTT600319S, RTT600496S, RTT600579S, RTT600591S, RTT600604S, RTT600607S, RTT600610S, RTT600612S, RTT600613S, RTT600614S, RTT600625S, RTT600881S, RTT600886S, RTT600919S, RTT600920S, RTT600921S, RTT600928S, RTT600934S, RTT600936S, RTT600937S, RTT600939S, RTT600941S, RTT600944S, RTT600945S, RTT600946S, RTT600947S, RTT600957S, RTT600974S, RTT600984S, RTT600988S, RTT601082S, RTT601084S, RTT601086S, RTT601087S, RTT601093S, RTT601094S, RTT601095S, RTT601096S, RTT601098S, RTT601104S, RTT601105S, RTT601106S, RTT601108S, RTT601111S, RTT601127S, RTT600449S, RTT600979S, RTT600620S, RTT600718S, RTT601083S", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide - Worldwide Distribution", "Status": "recorded" } } ] } ] }