ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1807-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; 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 DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1807-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1807-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1807-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1807-2023
      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 00643169837812, Lot Serial numbers: CWJ604194S, CWJ604707S, CWJ604057S, CWJ602128S, CWJ604288S, CWJ602870S, CWJ601914S, CWJ603587S, CWJ603802S, CWJ601000S, CWJ601001S, CWJ601158S, CWJ601706S, CWJ601799S, CWJ601845S, CWJ604343S, CWJ604387S, CWJ601910S, CWJ603379S, CWJ603449S, CWJ603454S, CWJ603109S, CWJ603385S, CWJ603717S, CWJ604036S, CWJ604043S, CWJ604092S, CWJ604118S, CWJ604397S, CWJ603165S, CWJ603501S, CWJ603684S, CWJ603685S, CWJ603693S, CWJ603831S, CWJ604218S, CWJ604314S, CWJ604338S, CWJ601875S, CWJ601903S, CWJ603686S, CWJ603836S, CWJ603869S, CWJ603875S, CWJ604377S, CWJ601894S, CWJ601905S, CWJ601909S, CWJ603429S, CWJ603660S, CWJ603060S, CWJ603731S, CWJ603760S, CWJ604336S, CWJ604355S, CWJ603859S, CWJ603697S, CWJ603700S, CWJ603849S, CWJ604337S, CWJ603687S, CWJ603695S, CWJ601906S, CWJ603445S, CWJ603873S, CWJ604179S, CWJ603842S, CWJ604042S, CWJ604094S, CWJ604339S, CWJ604358S, CWJ604117S, CWJ601891S, CWJ602956S, CWJ603275S, CWJ604684S, CWJ603881S, CWJ603884S, CWJ603939S, CWJ603957S, CWJ604167S, CWJ604178S, CWJ600977S, CWJ601408S, CWJ601788S, CWJ602434S, CWJ602745S, CWJ602880S, CWJ603241S, CWJ603297S, CWJ604580S, CWJ602700S, CWJ603061S, CWJ603107S, CWJ600881S, CWJ601208S, CWJ601611S, CWJ602039S, CWJ602115S, CWJ602503S, CWJ603723S, CWJ600971S, CWJ600974S, CWJ601067S, CWJ602190S, CWJ601175S, CWJ602150S, CWJ601675S, CWJ601315S, CWJ601498S, CWJ601661S, CWJ601714S, CWJ603486S, CWJ603828S, CWJ601669S, CWJ601686S, CWJ601724S, CWJ601911S, CWJ602067S, CWJ602106S, CWJ602168S, CWJ602176S, CWJ602271S, CWJ602425S, CWJ602629S, CWJ602701S, CWJ602702S, CWJ602725S, CWJ602821S, CWJ602881S, CWJ602895S, CWJ602899S, CWJ602963S, CWJ602984S, CWJ603144S, CWJ603150S, CWJ603254S, CWJ603293S, CWJ603313S, CWJ603328S, CWJ603368S, CWJ603369S, CWJ603370S, CWJ603416S, CWJ603467S, CWJ603471S, CWJ603491S, CWJ603610S, CWJ603621S, CWJ603623S, CWJ603646S, CWJ603774S, CWJ603786S, CWJ603805S, CWJ603848S, CWJ603882S, CWJ603887S, CWJ603894S, CWJ604025S, CWJ604054S, CWJ604107S, CWJ604187S, CWJ604196S, CWJ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1807-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1807-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; 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 00643169837812, Lot Serial numbers: CWJ604194S, CWJ604707S, CWJ604057S, CWJ602128S, CWJ604288S, CWJ602870S, CWJ601914S, CWJ603587S, CWJ603802S, CWJ601000S, CWJ601001S, CWJ601158S, CWJ601706S, CWJ601799S, CWJ601845S, CWJ604343S, CWJ604387S, CWJ601910S, CWJ603379S, CWJ603449S, CWJ603454S, CWJ603109S, CWJ603385S, CWJ603717S, CWJ604036S, CWJ604043S, CWJ604092S, CWJ604118S, CWJ604397S, CWJ603165S, CWJ603501S, CWJ603684S, CWJ603685S, CWJ603693S, CWJ603831S, CWJ604218S, CWJ604314S, CWJ604338S, CWJ601875S, CWJ601903S, CWJ603686S, CWJ603836S, CWJ603869S, CWJ603875S, CWJ604377S, CWJ601894S, CWJ601905S, CWJ601909S, CWJ603429S, CWJ603660S, CWJ603060S, CWJ603731S, CWJ603760S, CWJ604336S, CWJ604355S, CWJ603859S, CWJ603697S, CWJ603700S, CWJ603849S, CWJ604337S, CWJ603687S, CWJ603695S, CWJ601906S, CWJ603445S, CWJ603873S, CWJ604179S, CWJ603842S, CWJ604042S, CWJ604094S, CWJ604339S, CWJ604358S, CWJ604117S, CWJ601891S, CWJ602956S, CWJ603275S, CWJ604684S, CWJ603881S, CWJ603884S, CWJ603939S, CWJ603957S, CWJ604167S, CWJ604178S, CWJ600977S, CWJ601408S, CWJ601788S, CWJ602434S, CWJ602745S, CWJ602880S, CWJ603241S, CWJ603297S, CWJ604580S, CWJ602700S, CWJ603061S, CWJ603107S, CWJ600881S, CWJ601208S, CWJ601611S, CWJ602039S, CWJ602115S, CWJ602503S, CWJ603723S, CWJ600971S, CWJ600974S, CWJ601067S, CWJ602190S, CWJ601175S, CWJ602150S, CWJ601675S…
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-1807-2023 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.