ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1813-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; 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/
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: ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1813-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1813-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1813-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1813-2023
      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 I
      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., Cardiac Rhythm and Heart Failure (CRHF)
      status: recorded
  item list element: 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
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-05-10
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: GTIN 00643169720596, Lot Serial Numbers: PMZ618802S, PMZ616324S, PMZ616325S, PMZ618783S, PMZ614007S, PMZ616319S, PMZ616311S, PMZ616317S, PMZ616329S, PMZ614015S, PMZ614036S, PMZ616320S, PMZ613982S, PMZ615518S, PMZ616318S, PMZ616327S, PMZ618780S, PMZ618807S, PMZ618813S, PMZ616312S, PMZ616323S, PMZ618796S, PMZ619084S, PMZ618785S, PMZ616326S, PMZ618798S, PMZ614044S, PMZ612017S, PMZ612853S, PMZ613328S, PMZ613097S, PMZ614065S, PMZ614046S, PMZ613063S, PMZ613316S, PMZ614003S, PMZ614010S, PMZ614033S, PMZ614097S, PMZ613087S, PMZ613201S, PMZ614058S, PMZ614099S, PMZ613212S, PMZ613219S, PMZ613207S, PMZ613206S, PMZ613318S, PMZ613962S, PMZ614002S, PMZ613216S, PMZ613313S, PMZ613073S, PMZ613077S, PMZ613079S, PMZ613082S, PMZ613998S, PMZ613999S, PMZ614000S, PMZ614083S, PMZ614085S, PMZ614087S, PMZ614092S, PMZ614093S, PMZ613078S, PMZ614042S, PMZ613189S, PMZ613098S, PMZ613071S, PMZ613891S, PMZ613892S, PMZ613893S, PMZ613894S, PMZ613895S, PMZ614024S, PMZ614026S, PMZ614027S, PMZ614028S, PMZ614029S, PMZ614060S, PMZ614094S, PMZ615795S, PMZ614012S, PMZ614014S, PMZ614034S, PMZ613069S, PMZ614021S, PMZ614025S, PMZ614055S, PMZ613881S, PMZ614030S, PMZ614095S, PMZ613976S, PMZ613977S, PMZ614062S, PMZ614071S, PMZ613322S, PMZ613033S, PMZ613034S, PMZ613995S, PMZ613996S, PMZ614008S, PMZ614032S, PMZ614038S, PMZ614039S, PMZ613036S, PMZ613314S, PMZ613878S, PMZ613978S, PMZ614022S, PMZ613086S, PMZ614006S, PMZ614056S, PMZ613985S, PMZ614004S, PMZ614013S, PMZ614019S, PMZ614031S, PMZ613979S, PMZ613987S, PMZ613085S, PMZ613194S, PMZ614117S, PMZ613092S, PMZ613221S, PMZ613317S, PMZ613879S, PMZ614005S, PMZ613074S, PMZ614859S, PMZ613210S, PMZ613882S, PMZ613883S, PMZ613885S, PMZ613886S, PMZ613887S, PMZ613888S, PMZ613889S, PMZ613065S, PMZ613198S, PMZ613070S, PMZ614082S, PMZ614860S, PMZ613049S, PMZ613195S, PMZ613199S, PMZ613211S, PMZ613327S, PMZ613961S, PMZ613963S, PMZ614009S, PMZ614119S, PMZ614124S, PMZ614054S, PMZ614084S, PMZ616316S, PMZ613066S, PMZ613200S, PMZ613329S, PMZ614052S, PMZ613042S, PMZ613054S, PMZ613981S, PMZ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1813-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1813-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; 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 00643169720596, Lot Serial Numbers: PMZ618802S, PMZ616324S, PMZ616325S, PMZ618783S, PMZ614007S, PMZ616319S, PMZ616311S, PMZ616317S, PMZ616329S, PMZ614015S, PMZ614036S, PMZ616320S, PMZ613982S, PMZ615518S, PMZ616318S, PMZ616327S, PMZ618780S, PMZ618807S, PMZ618813S, PMZ616312S, PMZ616323S, PMZ618796S, PMZ619084S, PMZ618785S, PMZ616326S, PMZ618798S, PMZ614044S, PMZ612017S, PMZ612853S, PMZ613328S, PMZ613097S, PMZ614065S, PMZ614046S, PMZ613063S, PMZ613316S, PMZ614003S, PMZ614010S, PMZ614033S, PMZ614097S, PMZ613087S, PMZ613201S, PMZ614058S, PMZ614099S, PMZ613212S, PMZ613219S, PMZ613207S, PMZ613206S, PMZ613318S, PMZ613962S, PMZ614002S, PMZ613216S, PMZ613313S, PMZ613073S, PMZ613077S, PMZ613079S, PMZ613082S, PMZ613998S, PMZ613999S, PMZ614000S, PMZ614083S, PMZ614085S, PMZ614087S, PMZ614092S, PMZ614093S, PMZ613078S, PMZ614042S, PMZ613189S, PMZ613098S, PMZ613071S, PMZ613891S, PMZ613892S, PMZ613893S, PMZ613894S, PMZ613895S, PMZ614024S, PMZ614026S, PMZ614027S, PMZ614028S, PMZ614029S, PMZ614060S, PMZ614094S, PMZ615795S, PMZ614012S, PMZ614014S, PMZ614034S, PMZ613069S, PMZ614021S, PMZ614025S, PMZ614055S, PMZ613881S, PMZ614030S, PMZ614095S, PMZ613976S, PMZ613977S, PMZ614062S, PMZ614071S, PMZ613322S, PMZ613033S, PMZ613034S, PMZ613995S, PMZ613996S, PMZ614008S, PMZ614032S, PMZ614038S, PMZ614039S, PMZ613036S, PMZ613314S, PMZ613878S, PMZ…
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-1813-2023 as Class I
type: Claim
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.
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 I
  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.