{ "@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-2127-2025.jsonld", "@type": "schema:Dataset", "name": "Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1.\tAzure Astra application, Software Model Number D00U003; 2.\tPercepta Serena Solara application, Software Model Number D00U004; 3.\tCobalt Crome application, Software Model Number D00U005; 4.\tMicra VR application, Software Model Number D00U006; 5.\tMicra AV application, Software Model Number D00U007; 6.\tViva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7.\tClaria Amplia Compia application, Software Model Number D00U009; 8.\tEvera MRI application, Software Model Number D00U010; 9.\tVisia AF application, Software Model Number D00U011; 10.\tViva Brava Evera application, Software Model Number D00U012; 11.\tMicra VR2 AV2 application, Software Model Number D00U022.", "description": "FDA recall Z-2127-2025 — Medtronic, Inc. is recalling Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1.\tAzure Astra application, Software Model Number D00U003; 2.\tPercepta Serena Solara application, Software Model Number D00U004; 3.\tCobalt Crome application, Software Model Number D00U005; 4.\tMicra VR application, Software Model Number D00U006; 5.\tMicra AV application, Software Model Number D00U007; 6.\tViva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7.\tClaria Amplia Compia application, Software Model Number D00U009; 8.\tEvera MRI application, Software Model Number D00U010; 9.\tVisia AF application, Software Model Number D00U011; 10.\tViva Brava Evera application, Software Model Number D00U012; 11.\tMicra VR2 AV2 application, Software Model Number D00U022. (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-2127-2025&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1.\tAzure Astra application, Software Model Number D00U003; 2.\tPercepta Serena Solara application, Software Model Number D00U004; 3.\tCobalt Crome application, Software Model Number D00U005; 4.\tMicra VR application, Software Model Number D00U006; 5.\tMicra AV application, Software Model Number D00U007; 6.\tViva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7.\tClaria Amplia Compia application, Software Model Number D00U009; 8.\tEvera MRI application, Software Model Number D00U010; 9.\tVisia AF application, Software Model Number D00U011; 10.\tViva Brava Evera application, Software Model Number D00U012; 11.\tMicra VR2 AV2 application, Software Model Number D00U022.", "manufacturer": { "@type": "schema:Organization", "name": "Medtronic, Inc." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2127-2025/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-2127-2025: Medtronic, Inc. is recalling Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1.\tAzure Astra application, Software Model Number D00U003; 2.\tPercepta Serena Solara application, Software Model Number D00U004; 3.\tCobalt Crome application, Software Model Number D00U005; 4.\tMicra VR application, Software Model Number D00U006; 5.\tMicra AV application, Software Model Number D00U007; 6.\tViva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7.\tClaria Amplia Compia application, Software Model Number D00U009; 8.\tEvera MRI application, Software Model Number D00U010; 9.\tVisia AF application, Software Model Number D00U011; 10.\tViva Brava Evera application, Software Model Number D00U012; 11.\tMicra VR2 AV2 application, Software Model Number D00U022.", "text": "The FDA logged enforcement record Z-2127-2025: Medtronic, Inc. is voluntarily recalling Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1.\tAzure Astra application, Software Model Number D00U003; 2.\tPercepta Serena Solara application, Software Model Number D00U004; 3.\tCobalt Crome application, Software Model Number D00U005; 4.\tMicra VR application, Software Model Number D00U006; 5.\tMicra AV application, Software Model Number D00U007; 6.\tViva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7.\tClaria Amplia Compia application, Software Model Number D00U009; 8.\tEvera MRI application, Software Model Number D00U010; 9.\tVisia AF application, Software Model Number D00U011; 10.\tViva Brava Evera application, Software Model Number D00U012; 11.\tMicra VR2 AV2 application, Software Model Number D00U022. — reason: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-06-17. Affected lots/codes: 1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; 4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; 5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.. 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-2127-2025&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-2127-2025&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-2127-2025/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-2127-2025 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-2127-2025&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-2127-2025&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-2127-2025/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-2127-2025", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-2127-2025", "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": "Medtronic, Inc.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-06-17", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; 4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; 5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide", "Status": "recorded" } } ] } ] }