ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1805-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; 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 DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1805-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1805-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1805-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1805-2023
      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 00643169837805, Lot Serial Numbers: CWH604762S, CWH602704S, CWH604287S, CWH601113S, CWH602355S, CWH601417S, CWH601422S, CWH601423S, CWH603581S, CWH602459S, CWH602700S, CWH601632S, CWH601887S, CWH602686S, CWH602952S, CWH603048S, CWH604506S, CWH604849S, CWH605365S, CWH605366S, CWH605549S, CWH602311S, CWH603176S, CWH603389S, CWH601114S, CWH601326S, CWH601494S, CWH601599S, CWH601907S, CWH601934S, CWH602005S, CWH602031S, CWH602068S, CWH602379S, CWH602640S, CWH602643S, CWH602875S, CWH602966S, CWH603029S, CWH603161S, CWH603186S, CWH604179S, CWH604365S, CWH604848S, CWH605143S, CWH605152S, CWH605229S, CWH605231S, CWH601040S, CWH601241S, CWH602091S, CWH602139S, CWH602556S, CWH602717S, CWH603107S, CWH603227S, CWH603322S, CWH603327S, CWH603472S, CWH603986S, CWH604007S, CWH604304S, CWH604619S, CWH604856S, CWH604885S, CWH604939S, CWH604949S, CWH605132S, CWH605170S, CWH605306S, CWH605355S, CWH605386S, CWH605421S, CWH605553S, CWH601042S, CWH601324S, CWH601385S, CWH601970S, CWH602573S, CWH603036S, CWH603079S, CWH603431S, CWH603434S, CWH603477S, CWH603821S, CWH603840S, CWH603953S, CWH604240S, CWH604483S, CWH604632S, CWH604921S, CWH604975S, CWH605095S, CWH605179S, CWH605357S, CWH605359S, CWH605422S, CWH601010S, CWH601803S, CWH601935S, CWH601972S, CWH602411S, CWH602435S, CWH602708S, CWH602709S, CWH603306S, CWH603642S, CWH604021S, CWH604115S, CWH604160S, CWH604301S, CWH604344S, CWH604451S, CWH604587S, CWH604732S, CWH604811S, CWH604842S, CWH604918S, CWH604946S, CWH605157S, CWH605546S, CWH605547S, CWH604272S, CWH604844S, CWH604866S, CWH605116S, CWH600969S, CWH601002S, CWH601157S, CWH601160S, CWH601166S, CWH601244S, CWH601278S, CWH601297S, CWH601337S, CWH601343S, CWH601371S, CWH601485S, CWH601499S, CWH601787S, CWH601797S, CWH601804S, CWH601829S, CWH601902S, CWH601931S, CWH601968S, CWH602000S, CWH602030S, CWH602034S, CWH602165S, CWH602254S, CWH602270S, CWH602294S, CWH602309S, CWH602329S, CWH602409S, CWH602658S, CWH602743S, CWH602772S, CWH602947S, CWH602949S, CWH603039S, CWH603041S, CWH…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1805-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1805-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; 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 00643169837805, Lot Serial Numbers: CWH604762S, CWH602704S, CWH604287S, CWH601113S, CWH602355S, CWH601417S, CWH601422S, CWH601423S, CWH603581S, CWH602459S, CWH602700S, CWH601632S, CWH601887S, CWH602686S, CWH602952S, CWH603048S, CWH604506S, CWH604849S, CWH605365S, CWH605366S, CWH605549S, CWH602311S, CWH603176S, CWH603389S, CWH601114S, CWH601326S, CWH601494S, CWH601599S, CWH601907S, CWH601934S, CWH602005S, CWH602031S, CWH602068S, CWH602379S, CWH602640S, CWH602643S, CWH602875S, CWH602966S, CWH603029S, CWH603161S, CWH603186S, CWH604179S, CWH604365S, CWH604848S, CWH605143S, CWH605152S, CWH605229S, CWH605231S, CWH601040S, CWH601241S, CWH602091S, CWH602139S, CWH602556S, CWH602717S, CWH603107S, CWH603227S, CWH603322S, CWH603327S, CWH603472S, CWH603986S, CWH604007S, CWH604304S, CWH604619S, CWH604856S, CWH604885S, CWH604939S, CWH604949S, CWH605132S, CWH605170S, CWH605306S, CWH605355S, CWH605386S, CWH605421S, CWH605553S, CWH601042S, CWH601324S, CWH601385S, CWH601970S, CWH602573S, CWH603036S, CWH603079S, CWH603431S, CWH603434S, CWH603477S, CWH603821S, CWH603840S, CWH603953S, CWH604240S, CWH604483S, CWH604632S, CWH604921S, CWH604975S, CWH605095S, CWH605179S, CWH605357S, CWH605359S, CWH605422S, CWH601010S, CWH601803S, CWH601935S, CWH601972S, CWH602411S, CWH602435S, CWH602708S, CWH602709S, CWH603306S, CWH603642S, CWH604021S, …
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-1805-2023 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.