Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
type: Dataset
description: FDA recall Z-0726-2026 — Medtronic, Inc. is recalling Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 (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/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
  type: MedicalDevice
  manufacturer: Medtronic, Inc.
claims: FDA recall Z-0726-2026: Medtronic, Inc. is recalling Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
claims: FDA classified recall Z-0726-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0726-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0726-2026
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Medtronic, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-10-29
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: 00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694; Serial Numbers: EVS600036S EVS600038S EVS600034S EVS600044S EVS600033S EVS600048S EVS600049S EVS600139S EVS600039S EVS600040S EVS600056S EVS600140S EVS600075S EVS600149S EVS600060S EVS600157S EVS600032S EVS600154S EVS600161S EVS600045S EVS600050S EVS600150S EVS600061S EVS600064S EVS600065S EVS600178S EVS600201S EVS600058S EVS600180S EVS600168S EVS600156S EVS600057S EVS600212S EVS600164S EVS600155S EVS600167S EVS600134S EVS600209S EVS600177S EVS600170S EVS600055S EVS600220S EVS600236S EVS600141S EVS600166S EVS600254S EVS600211S EVS600234S EVS600142S EVS600357S EVS600353S EVS600210S EVS600354S EVS600218S EVS600364S EVS600348S EVS600374S EVS600369S EVS600384S EVS600343S EVS600207S EVS600371S EVS600389S EVS600053S EVS600135S EVS600367S EVS600206S EVS600349S EVS600344S EVS600408S EVS600365S EVS600407S EVS600052S EVS600203S EVS600350S EVS600411S EVS600412S EVS600051S EVS600397S EVS600400S EVS600423S EVS600165S EVS600390S EVS600351S EVS600370S EVS600641S EVS600368S EVS600216S EVS600382S EVS600199S EVS600208S EVS600399S EVS600380S EVS600221S EVS600415S EVS600073S EVS600205S EVS600159S EVS600239S EVS600179S EVS600642S EVS600671S EVS600646S EVS600648S EVS600658S EVS600660S EVS600649S EVS600651S EVS600669S EVS600657S EVS600643S EVS600672S EVS600670S EVS600681S EVS600680S EVS600676S EVS600683S EVS600679S EVS600673S EVS600686S EVS600653S EVS600654S EVS600665S EVS600741S EVS600743S EVS600745S EVS600153S EVS600650S EVS600663S EVS600656S EVS600666S EVS600675S EVS600281S EVS600095S EVS600096S EVS600011S EVS600097S EVS600255S EVS600074S EVS600085S EVS600247S EVS600252S EVS600094S EVS600086S EVS600266S EVS600267S EVS600502S EVS600314S EVS600277S EVS600303S EVS600304S EVS600305S EVS600272S EVS600273S EVS600012S EVS600013S EVS600015S EVS600016S EVS600027S EVS600315S EVS600313S EVS600316S EVS600317S EVS600318S EVS600571S EVS600572S EVS600307S EVS600308S EVS600573S EVS600575S EVS600612S…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution.
      status: recorded

FDA recall Z-0726-2026: Medtronic, Inc. is recalling Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
type: Claim
text: The FDA logged enforcement record Z-0726-2026: Medtronic, Inc. is voluntarily recalling Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 — reason: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-29. Affected lots/codes: UDI-DI: 00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694; Serial Numbers: EVS600036S EVS600038S EVS600034S EVS600044S EVS600033S EVS600048S EVS600049S EVS600139S EVS600039S EVS600040S EVS600056S EVS600140S EVS600075S EVS600149S EVS600060S EVS600157S EVS600032S EVS600154S EVS600161S EVS600045S EVS600050S EVS600150S EVS600061S EVS600064S EVS600065S EVS600178S EVS600201S EVS600058S EVS600180S EVS600168S EVS600156S EVS600057S EVS600212S EVS600164S EVS600155S EVS600167S EVS600134S EVS600209S EVS600177S EVS600170S EVS600055S EVS600220S EVS600236S EVS600141S EVS600166S EVS600254S EVS600211S EVS600234S EVS600142S EVS600357S EVS600353S EVS600210S EVS600354S EVS600218S EVS600364S EVS600348S EVS600374S EVS600369S EVS600384S EVS600343S EVS600207S EVS600371S EVS600389S EVS600053S EVS600135S EVS600367S EVS600206S EVS600349S EVS600344S EVS600408S EVS600365S EVS600407S EVS600052S EVS600203S EVS600350S EVS600411S EVS600412S EVS600051S EVS600397S EVS600400S EVS600423S EVS600165S EVS600390S EVS600351S EVS600370S EVS600641S EVS600368S EVS600216S EVS600382S EVS600199S EVS600208S EVS600399S EVS600380S EVS600221S EVS600415S EVS600073S EVS600205S EVS600159S EVS600239S EVS600179S EVS600642S EVS600671S EVS600646S EVS600648S EVS600658S EVS600660S EVS600649S EVS600651S EVS600669S EVS600657S EVS600643S EVS600672S EVS600670S EVS600681S EVS600680S EVS600676S EVS600683S EVS600679S EVS600673S EVS600686S EVS600653S EVS600654S EVS600665S EVS600741S EVS600743S EVS600745S EVS600153S EVS600650S EVS600663S EVS600656S EVS60066…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
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.

FDA classified recall Z-0726-2026 as Class II
type: Claim
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.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
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.

What an FDA recall is — and is NOT
type: Claim
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.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
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.