ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1803-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; 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 DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1803-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1803-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1803-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1803-2023
      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 00643169837799, Lot Serial Numbers: CWG208686H, CWG211264H, CWG205930H, CWG208117H, CWG210956H, CWG210958H, CWG211814H, CWG212178H, CWG208135H, CWG209489H, CWG209599H, CWG212702H, CWG214349H, CWG214379H, CWG206584H, CWG208347H, CWG206776H, CWG206895H, CWG211478H, CWG211709H, CWG212079H, CWG212183H, CWG212836H, CWG205283H, CWG205284H, CWG205288H, CWG207805H, CWG207808H, CWG207809H, CWG207810H, CWG207811H, CWG207812H, CWG208949H, CWG209030H, CWG209031H, CWG209285H, CWG209646H, CWG209659H, CWG209823H, CWG210928H, CWG210929H, CWG211866H, CWG212840H, CWG212841H, CWG212842H, CWG212843H, CWG212844H, CWG212846H, CWG212847H, CWG212851H, CWG212853H, CWG212854H, CWG213620H, CWG213622H, CWG213623H, CWG206242H, CWG206868H, CWG209799H, CWG212914H, CWG205298H, CWG205299H, CWG205450H, CWG205777H, CWG206838H, CWG206972H, CWG208335H, CWG208502H, CWG209280H, CWG209978H, CWG209979H, CWG209981H, CWG209982H, CWG209983H, CWG211070H, CWG211071H, CWG211072H, CWG211696H, CWG212566H, CWG212568H, CWG212569H, CWG213285H, CWG213505H, CWG213756H, CWG214277H, CWG214324H, CWG204936H, CWG205368H, CWG206168H, CWG208188H, CWG208467H, CWG213778H, CWG206589H, CWG206593H, CWG209988H, CWG210659H, CWG213726H, CWG213727H, CWG213728H, CWG208549H, CWG213157H, CWG206078H, CWG206763H, CWG207072H, CWG207829H, CWG207979H, CWG209086H, CWG209271H, CWG209763H, CWG211506H, CWG213628H, CWG214299H, CWG206015H, CWG206115H, CWG206347H, CWG206398H, CWG206864H, CWG207060H, CWG207230H, CWG208431H, CWG208825H, CWG208869H, CWG209569H, CWG212666H, CWG207012H, CWG209624H, CWG205839H, CWG206775H, CWG208030H, CWG208084H, CWG208184H, CWG208744H, CWG209781H, CWG210362H, CWG210390H, CWG211194H, CWG211301H, CWG211817H, CWG212533H, CWG212552H, CWG214390H, CWG207167H, CWG204969H, CWG206871H, CWG209061H, CWG210696H, CWG211027H, CWG211028H, CWG208153H, CWG207295H, CWG207567H, CWG207715H, CWG213540H, CWG208792H, CWG214152H, CWG211554H, CWG212531H, CWG206039H, CWG206385H, CWG212687H, CWG213369H, CWG205033H, CWG205702H, CWG207326H, CWG…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1803-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1803-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; 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 00643169837799, Lot Serial Numbers: CWG208686H, CWG211264H, CWG205930H, CWG208117H, CWG210956H, CWG210958H, CWG211814H, CWG212178H, CWG208135H, CWG209489H, CWG209599H, CWG212702H, CWG214349H, CWG214379H, CWG206584H, CWG208347H, CWG206776H, CWG206895H, CWG211478H, CWG211709H, CWG212079H, CWG212183H, CWG212836H, CWG205283H, CWG205284H, CWG205288H, CWG207805H, CWG207808H, CWG207809H, CWG207810H, CWG207811H, CWG207812H, CWG208949H, CWG209030H, CWG209031H, CWG209285H, CWG209646H, CWG209659H, CWG209823H, CWG210928H, CWG210929H, CWG211866H, CWG212840H, CWG212841H, CWG212842H, CWG212843H, CWG212844H, CWG212846H, CWG212847H, CWG212851H, CWG212853H, CWG212854H, CWG213620H, CWG213622H, CWG213623H, CWG206242H, CWG206868H, CWG209799H, CWG212914H, CWG205298H, CWG205299H, CWG205450H, CWG205777H, CWG206838H, CWG206972H, CWG208335H, CWG208502H, CWG209280H, CWG209978H, CWG209979H, CWG209981H, CWG209982H, CWG209983H, CWG211070H, CWG211071H, CWG211072H, CWG211696H, CWG212566H, CWG212568H, CWG212569H, CWG213285H, CWG213505H, CWG213756H, CWG214277H, CWG214324H, CWG204936H, CWG205368H, CWG206168H, CWG208188H, CWG208467H, CWG213778H, CWG206589H, CWG206593H, CWG209988H, CWG210659H, CWG213726H, CWG213727H, CWG213728H, CWG208549H, CWG213157H, CWG206078H, CWG206763H, CWG207072H, CWG207829H, CWG207979H, CWG209086H, CWG209271H, CWG209763H, CWG2…
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-1803-2023 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.