ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1812-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; 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 DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1812-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1812-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1812-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1812-2023
      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 00643169837775, Lot Serial Numbers: CWF606066S, CWF601772S, CWF604835S, CWF604967S, CWF605332S, CWF601390S, CWF603522S, CWF602774S, CWF605900S, CWF600919S, CWF600938S, CWF601256S, CWF601551S, CWF601593S, CWF601753S, CWF601934S, CWF601936S, CWF602109S, CWF602581S, CWF602772S, CWF603413S, CWF603447S, CWF605891S, CWF602270S, CWF602324S, CWF602338S, CWF602553S, CWF602554S, CWF602674S, CWF602675S, CWF602677S, CWF602751S, CWF602752S, CWF602816S, CWF602823S, CWF602996S, CWF602998S, CWF603000S, CWF603013S, CWF603171S, CWF603174S, CWF603319S, CWF603361S, CWF603362S, CWF603363S, CWF603393S, CWF603406S, CWF603408S, CWF603718S, CWF603720S, CWF603721S, CWF603829S, CWF603830S, CWF603831S, CWF603832S, CWF603925S, CWF603931S, CWF603944S, CWF603996S, CWF603999S, CWF604002S, CWF604003S, CWF604004S, CWF604007S, CWF604008S, CWF604010S, CWF604598S, CWF604686S, CWF604814S, CWF604816S, CWF606151S, CWF606180S, CWF601291S, CWF601561S, CWF601672S, CWF601977S, CWF602155S, CWF606035S, CWF601562S, CWF601736S, CWF601666S, CWF602110S, CWF601293S, CWF601557S, CWF601667S, CWF601782S, CWF602154S, CWF601290S, CWF601563S, CWF605395S, CWF601668S, CWF601669S, CWF601675S, CWF606033S, CWF602902S, CWF601471S, CWF602974S, CWF603047S, CWF602754S, CWF603306S, CWF603470S, CWF603528S, CWF603652S, CWF603703S, CWF604018S, CWF604422S, CWF602486S, CWF600962S, CWF601720S, CWF603131S, CWF600875S, CWF601119S, CWF601286S, CWF601386S, CWF602245S, CWF602849S, CWF603471S, CWF603642S, CWF604496S, CWF602510S, CWF604175S, CWF604270S, CWF601628S, CWF602623S, CWF600890S, CWF601153S, CWF603356S, CWF604107S, CWF601152S, CWF601472S, CWF602386S, CWF602753S, CWF602893S, CWF603040S, CWF603073S, CWF603602S, CWF603706S, CWF603890S, CWF604344S, CWF604405S, CWF604454S, CWF604567S, CWF604578S, CWF604604S, CWF604722S, CWF604763S, CWF605154S, CWF606022S, CWF600881S, CWF601320S, CWF601907S, CWF602237S, CWF602362S, CWF603398S, CWF604420S, CWF601583S, CWF602843S, CWF603667S, CWF601414S, CWF603923S, CWF602092S, CWF603065S, CWF602073S, CWF…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1812-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1812-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; 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 00643169837775, Lot Serial Numbers: CWF606066S, CWF601772S, CWF604835S, CWF604967S, CWF605332S, CWF601390S, CWF603522S, CWF602774S, CWF605900S, CWF600919S, CWF600938S, CWF601256S, CWF601551S, CWF601593S, CWF601753S, CWF601934S, CWF601936S, CWF602109S, CWF602581S, CWF602772S, CWF603413S, CWF603447S, CWF605891S, CWF602270S, CWF602324S, CWF602338S, CWF602553S, CWF602554S, CWF602674S, CWF602675S, CWF602677S, CWF602751S, CWF602752S, CWF602816S, CWF602823S, CWF602996S, CWF602998S, CWF603000S, CWF603013S, CWF603171S, CWF603174S, CWF603319S, CWF603361S, CWF603362S, CWF603363S, CWF603393S, CWF603406S, CWF603408S, CWF603718S, CWF603720S, CWF603721S, CWF603829S, CWF603830S, CWF603831S, CWF603832S, CWF603925S, CWF603931S, CWF603944S, CWF603996S, CWF603999S, CWF604002S, CWF604003S, CWF604004S, CWF604007S, CWF604008S, CWF604010S, CWF604598S, CWF604686S, CWF604814S, CWF604816S, CWF606151S, CWF606180S, CWF601291S, CWF601561S, CWF601672S, CWF601977S, CWF602155S, CWF606035S, CWF601562S, CWF601736S, CWF601666S, CWF602110S, CWF601293S, CWF601557S, CWF601667S, CWF601782S, CWF602154S, CWF601290S, CWF601563S, CWF605395S, CWF601668S, CWF601669S, CWF601675S, CWF606033S, CWF602902S, CWF601471S, CWF602974S, CWF603047S, CWF602754S, CWF603306S, CWF603470S, CWF603528S, CWF603652S, CWF603703S, CWF604018S, CWF604422S, CWF602486S, CWF600962S, C…
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-1812-2023 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.