ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1808-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; 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 VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1808-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1808-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1808-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1808-2023
      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 00643169720817. Lot Serial Numbers: PMX613090S, PMX610759S, PMX613168S, PMX604899S, PMX606600S, PMX605030S, PMX605294S, PMX605321S, PMX605409S, PMX605434S, PMX605494S, PMX605615S, PMX605865S, PMX605971S, PMX606147S, PMX606694S, PMX606698S, PMX606701S, PMX606703S, PMX606705S, PMX606859S, PMX607270S, PMX608318S, PMX611103S, PMX613896S, PMX613927S, PMX613944S, PMX612024S, PMX613712S, PMX613935S, PMX613953S, PMX611975S, PMX613088S, PMX613697S, PMX613929S, PMX613942S, PMX607559S, PMX611696S, PMX611976S, PMX611873S, PMX607595S, PMX611948S, PMX607298S, PMX611887S, PMX612112S, PMX607539S, PMX607632S, PMX611052S, PMX612018S, PMX612108S, PMX613774S, PMX613790S, PMX607549S, PMX607599S, PMX612009S, PMX612016S, PMX612119S, PMX613709S, PMX613954S, PMX609256S, PMX607521S, PMX607529S, PMX607532S, PMX607737S, PMX607742S, PMX611286S, PMX611299S, PMX611303S, PMX611687S, PMX611688S, PMX611987S, PMX612005S, PMX612008S, PMX612019S, PMX612114S, PMX612118S, PMX613076S, PMX613077S, PMX613081S, PMX613312S, PMX613324S, PMX613437S, PMX613536S, PMX613539S, PMX613558S, PMX613561S, PMX613695S, PMX613702S, PMX613708S, PMX613711S, PMX613931S, PMX614118S, PMX614120S, PMX607517S, PMX607520S, PMX607545S, PMX607700S, PMX613443S, PMX613446S, PMX613542S, PMX613710S, PMX613714S, PMX607575S, PMX612116S, PMX613093S, PMX613328S, PMX613440S, PMX613441S, PMX607515S, PMX607524S, PMX607525S, PMX607526S, PMX607300S, PMX611159S, PMX611998S, PMX611878S, PMX611229S, PMX607516S, PMX609678S, PMX609772S, PMX611228S, PMX611275S, PMX611289S, PMX611294S, PMX611872S, PMX611879S, PMX611881S, PMX611995S, PMX611996S, PMX611997S, PMX612004S, PMX612006S, PMX612010S, PMX612013S, PMX612015S, PMX613246S, PMX613320S, PMX613448S, PMX613481S, PMX613562S, PMX613762S, PMX613938S, PMX613947S, PMX613959S, PMX605677S, PMX605029S, PMX604766S, PMX607432S, PMX607437S, PMX607733S, PMX609761S, PMX610167S, PMX610755S, PMX611397S, PMX611398S, PMX611574S, PMX613384S, PMX613568S, PMX612508S, PMX612649S, PMX613273S, PMX613486S, PMX614055S, PMX…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1808-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1808-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; 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 00643169720817. Lot Serial Numbers: PMX613090S, PMX610759S, PMX613168S, PMX604899S, PMX606600S, PMX605030S, PMX605294S, PMX605321S, PMX605409S, PMX605434S, PMX605494S, PMX605615S, PMX605865S, PMX605971S, PMX606147S, PMX606694S, PMX606698S, PMX606701S, PMX606703S, PMX606705S, PMX606859S, PMX607270S, PMX608318S, PMX611103S, PMX613896S, PMX613927S, PMX613944S, PMX612024S, PMX613712S, PMX613935S, PMX613953S, PMX611975S, PMX613088S, PMX613697S, PMX613929S, PMX613942S, PMX607559S, PMX611696S, PMX611976S, PMX611873S, PMX607595S, PMX611948S, PMX607298S, PMX611887S, PMX612112S, PMX607539S, PMX607632S, PMX611052S, PMX612018S, PMX612108S, PMX613774S, PMX613790S, PMX607549S, PMX607599S, PMX612009S, PMX612016S, PMX612119S, PMX613709S, PMX613954S, PMX609256S, PMX607521S, PMX607529S, PMX607532S, PMX607737S, PMX607742S, PMX611286S, PMX611299S, PMX611303S, PMX611687S, PMX611688S, PMX611987S, PMX612005S, PMX612008S, PMX612019S, PMX612114S, PMX612118S, PMX613076S, PMX613077S, PMX613081S, PMX613312S, PMX613324S, PMX613437S, PMX613536S, PMX613539S, PMX613558S, PMX613561S, PMX613695S, PMX613702S, PMX613708S, PMX613711S, PMX613931S, PMX614118S, PMX614120S, PMX607517S, PMX607520S, PMX607545S, PMX607700S, PMX613443S, PMX613446S, PMX613542S, PMX613710S, PMX613714S, PMX607575S, PMX612116S, PMX613093S, PMX613328S, PMX613440S, PMX613441S, PMX607…
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-1808-2023 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.