ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1804-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; 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 DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1804-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1804-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1804-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1804-2023
      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 00643169720794, Lot Serial Numbers: PKX219646H, PKX220040H, PKX220056H, PKX221681H, PKX222407H, PKX222934H, PKX223422H, PKX225541H, PKX228394H, PKX228784H, PKX228814H, PKX230405H, PKX231486H, PKX232877H, PKX233043H, PKX236253H, PKX238847H, PKX238969H, PKX224741H, PKX224742H, PKX226542H, PKX230306H, PKX231799H, PKX231802H, PKX234882H, PKX234889H, PKX236705H, PKX236715H, PKX239415H, PKX240693H, PKX234754H, PKX237931H, PKX221151H, PKX222802H, PKX224257H, PKX227009H, PKX227059H, PKX227453H, PKX229189H, PKX231976H, PKX232346H, PKX233404H, PKX235182H, PKX236627H, PKX240315H, PKX219199H, PKX221009H, PKX221252H, PKX221253H, PKX221256H, PKX221257H, PKX221262H, PKX221264H, PKX221271H, PKX221272H, PKX221273H, PKX221276H, PKX224585H, PKX224586H, PKX224589H, PKX224590H, PKX224592H, PKX224593H, PKX224594H, PKX224595H, PKX229231H, PKX229232H, PKX229234H, PKX229237H, PKX229239H, PKX229240H, PKX230943H, PKX230945H, PKX230956H, PKX230960H, PKX230961H, PKX230962H, PKX230965H, PKX230967H, PKX234196H, PKX234197H, PKX234214H, PKX234215H, PKX234216H, PKX234217H, PKX234220H, PKX234221H, PKX236947H, PKX237017H, PKX237021H, PKX237022H, PKX237023H, PKX237024H, PKX237037H, PKX237040H, PKX237043H, PKX237044H, PKX237045H, PKX237046H, PKX237048H, PKX237049H, PKX237051H, PKX237052H, PKX237054H, PKX237055H, PKX237056H, PKX239045H, PKX239046H, PKX239050H, PKX239053H, PKX239056H, PKX239057H, PKX239063H, PKX239064H, PKX239065H, PKX239066H, PKX239067H, PKX239068H, PKX239069H, PKX218877H, PKX221372H, PKX221452H, PKX221877H, PKX222446H, PKX224263H, PKX225312H, PKX225546H, PKX227161H, PKX228117H, PKX228815H, PKX228816H, PKX229323H, PKX230703H, PKX232371H, PKX233385H, PKX233534H, PKX234142H, PKX234885H, PKX235109H, PKX235523H, PKX235764H, PKX237365H, PKX237711H, PKX237771H, PKX239911H, PKX222254H, PKX225474H, PKX227405H, PKX230389H, PKX231519H, PKX231797H, PKX233081H, PKX233268H, PKX233842H, PKX235225H, PKX235355H, PKX238652H, PKX239523H, PKX239862H, PKX239109H, PKX239281H, PKX220770H, PKX220852H, PKX…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1804-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1804-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; 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 00643169720794, Lot Serial Numbers: PKX219646H, PKX220040H, PKX220056H, PKX221681H, PKX222407H, PKX222934H, PKX223422H, PKX225541H, PKX228394H, PKX228784H, PKX228814H, PKX230405H, PKX231486H, PKX232877H, PKX233043H, PKX236253H, PKX238847H, PKX238969H, PKX224741H, PKX224742H, PKX226542H, PKX230306H, PKX231799H, PKX231802H, PKX234882H, PKX234889H, PKX236705H, PKX236715H, PKX239415H, PKX240693H, PKX234754H, PKX237931H, PKX221151H, PKX222802H, PKX224257H, PKX227009H, PKX227059H, PKX227453H, PKX229189H, PKX231976H, PKX232346H, PKX233404H, PKX235182H, PKX236627H, PKX240315H, PKX219199H, PKX221009H, PKX221252H, PKX221253H, PKX221256H, PKX221257H, PKX221262H, PKX221264H, PKX221271H, PKX221272H, PKX221273H, PKX221276H, PKX224585H, PKX224586H, PKX224589H, PKX224590H, PKX224592H, PKX224593H, PKX224594H, PKX224595H, PKX229231H, PKX229232H, PKX229234H, PKX229237H, PKX229239H, PKX229240H, PKX230943H, PKX230945H, PKX230956H, PKX230960H, PKX230961H, PKX230962H, PKX230965H, PKX230967H, PKX234196H, PKX234197H, PKX234214H, PKX234215H, PKX234216H, PKX234217H, PKX234220H, PKX234221H, PKX236947H, PKX237017H, PKX237021H, PKX237022H, PKX237023H, PKX237024H, PKX237037H, PKX237040H, PKX237043H, PKX237044H, PKX237045H, PKX237046H, PKX237048H, PKX237049H, PKX237051H, PKX237052H, PKX237054H, PKX237055H, PKX237056H, PKX239045H, PKX239046H, PKX2…
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-1804-2023 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.