ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1817-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; 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 DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1817-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1817-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1817-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1817-2023
      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 00763000001629, Lot Serial Numbers: CWR601226S, CWR601747S, CWR614516S, CWR615056S, CWR611693S, CWR610177S, CWR613808S, CWR600732S, CWR606430S, CWR602651S, CWR607356S, CWR610310S, CWR604045S, CWR603303S, CWR609623S, CWR605872S, CWR601687S, CWR603211S, CWR602807S, CWR607694S, CWR613692S, CWR613696S, CWR605094S, CWR610428S, CWR606832S, CWR607019S, CWR612869S, CWR614166S, CWR614552S, CWR608782S, CWR611713S, CWR614839S, CWR613888S, CWR614119S, CWR614102S, CWR614110S, CWR613089S, CWR612399S, CWR608766S, CWR614937S, CWR612224S, CWR614130S, CWR612786S, CWR614153S, CWR613324S, CWR612299S, CWR612283S, CWR612754S, CWR610251S, CWR610659S, CWR604739S, CWR605422S, CWR605753S, CWR606253S, CWR607872S, CWR609650S, CWR613342S, CWR606875S, CWR601224S, CWR601549S, CWR601550S, CWR602194S, CWR603281S, CWR603711S, CWR604836S, CWR605024S, CWR605378S, CWR606857S, CWR609093S, CWR600564S, CWR601374S, CWR601412S, CWR602016S, CWR602048S, CWR602172S, CWR602215S, CWR602229S, CWR602850S, CWR604727S, CWR604841S, CWR605233S, CWR605740S, CWR606077S, CWR606621S, CWR607419S, CWR607905S, CWR609837S, CWR609987S, CWR610588S, CWR611070S, CWR611189S, CWR611604S, CWR611683S, CWR613086S, CWR614108S, CWR614126S, CWR614582S, CWR600290S, CWR600798S, CWR600903S, CWR601809S, CWR601823S, CWR602693S, CWR600201S, CWR600280S, CWR600780S, CWR601028S, CWR601781S, CWR602187S, CWR602514S, CWR602565S, CWR602736S, CWR602986S, CWR603209S, CWR605149S, CWR605488S, CWR605758S, CWR605886S, CWR606853S, CWR608265S, CWR609492S, CWR610199S, CWR612442S, CWR614545S, CWR600252S, CWR600345S, CWR600458S, CWR600856S, CWR600956S, CWR601014S, CWR601183S, CWR601314S, CWR601340S, CWR601732S, CWR602038S, CWR602235S, CWR602603S, CWR602654S, CWR602806S, CWR603666S, CWR604043S, CWR604120S, CWR604188S, CWR604327S, CWR604432S, CWR604449S, CWR604644S, CWR604786S, CWR604927S, CWR605399S, CWR605686S, CWR606156S, CWR606532S, CWR607809S, CWR608344S, CWR609044S, CWR609654S, CWR609994S, CWR610033S, CWR610060S, CWR611609S, CWR613391S, CWR605551S, CWR…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1817-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1817-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; 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 00763000001629, Lot Serial Numbers: CWR601226S, CWR601747S, CWR614516S, CWR615056S, CWR611693S, CWR610177S, CWR613808S, CWR600732S, CWR606430S, CWR602651S, CWR607356S, CWR610310S, CWR604045S, CWR603303S, CWR609623S, CWR605872S, CWR601687S, CWR603211S, CWR602807S, CWR607694S, CWR613692S, CWR613696S, CWR605094S, CWR610428S, CWR606832S, CWR607019S, CWR612869S, CWR614166S, CWR614552S, CWR608782S, CWR611713S, CWR614839S, CWR613888S, CWR614119S, CWR614102S, CWR614110S, CWR613089S, CWR612399S, CWR608766S, CWR614937S, CWR612224S, CWR614130S, CWR612786S, CWR614153S, CWR613324S, CWR612299S, CWR612283S, CWR612754S, CWR610251S, CWR610659S, CWR604739S, CWR605422S, CWR605753S, CWR606253S, CWR607872S, CWR609650S, CWR613342S, CWR606875S, CWR601224S, CWR601549S, CWR601550S, CWR602194S, CWR603281S, CWR603711S, CWR604836S, CWR605024S, CWR605378S, CWR606857S, CWR609093S, CWR600564S, CWR601374S, CWR601412S, CWR602016S, CWR602048S, CWR602172S, CWR602215S, CWR602229S, CWR602850S, CWR604727S, CWR604841S, CWR605233S, CWR605740S, CWR606077S, CWR606621S, CWR607419S, CWR607905S, CWR609837S, CWR609987S, CWR610588S, CWR611070S, CWR611189S, CWR611604S, CWR611683S, CWR613086S, CWR614108S, CWR614126S, CWR614582S, CWR600290S, CWR600798S, CWR600903S, CWR601809S, CWR601823S, CWR602693S, CWR600201S, CWR600280S, CWR600780S, CWR601028S, CWR601781S, CWR602187S, CW…
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-1817-2023 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.