ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1806-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; 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 XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1806-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1806-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1806-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1806-2023
      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 00643169717992, Lot Serial Numbers: PLX607314S, PLX608121S, PLX612778S, PLX613087S, PLX604547S, PLX610926S, PLX606361S, PLX608125S, PLX610724S, PLX610983S, PLX609285S, PLX608127S, PLX608938S, PLX610866S, PLX612123S, PLX608086S, PLX608118S, PLX609410S, PLX610864S, PLX610961S, PLX610967S, PLX611934S, PLX611951S, PLX614024S, PLX614073S, PLX608054S, PLX605322S, PLX614114S, PLX607228S, PLX607330S, PLX607943S, PLX613085S, PLX609803S, PLX607928S, PLX605323S, PLX607310S, PLX607333S, PLX606750S, PLX608915S, PLX608983S, PLX609494S, PLX610736S, PLX610740S, PLX610953S, PLX610949S, PLX612097S, PLX608914S, PLX607332S, PLX607785S, PLX607788S, PLX609693S, PLX609858S, PLX608510S, PLX607200S, PLX610731S, PLX606698S, PLX607506S, PLX610276S, PLX606134S, PLX605235S, PLX606368S, PLX612749S, PLX607386S, PLX606748S, PLX610920S, PLX614233S, PLX607508S, PLX612649S, PLX612650S, PLX608980S, PLX609862S, PLX604556S, PLX610980S, PLX607566S, PLX608469S, PLX610900S, PLX606141S, PLX608096S, PLX608113S, PLX609491S, PLX609859S, PLX611893S, PLX611897S, PLX608092S, PLX607939S, PLX608401S, PLX608994S, PLX606341S, PLX609486S, PLX608954S, PLX604652S, PLX605335S, PLX605336S, PLX606958S, PLX610935S, PLX612860S, PLX609834S, PLX607784S, PLX607327S, PLX607665S, PLX609533S, PLX610317S, PLX611000S, PLX614302S, PLX605298S, PLX608179S, PLX606993S, PLX607676S, PLX609003S, PLX609006S, PLX609529S, PLX612993S, PLX607312S, PLX610951S, PLX611042S, PLX608106S, PLX609230S, PLX610912S, PLX611002S, PLX609875S, PLX612480S, PLX608117S, PLX612626S, PLX610879S, PLX610956S, PLX609535S, PLX609030S, PLX610880S, PLX608102S, PLX609863S, PLX608407S, PLX609093S, PLX612001S, PLX612620S, PLX607820S, PLX609700S, PLX606346S, PLX612136S, PLX605171S, PLX605241S, PLX607317S, PLX607938S, PLX609881S, PLX606454S, PLX606369S, PLX607945S, PLX608186S, PLX612621S, PLX605330S, PLX607808S, PLX608109S, PLX609530S, PLX609868S, PLX612624S, PLX612647S, PLX604641S, PLX604725S, PLX605300S, PLX605301S, PLX606159S, PLX608165S, PLX609066S, PLX610313S, PLX…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1806-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1806-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; 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 00643169717992, Lot Serial Numbers: PLX607314S, PLX608121S, PLX612778S, PLX613087S, PLX604547S, PLX610926S, PLX606361S, PLX608125S, PLX610724S, PLX610983S, PLX609285S, PLX608127S, PLX608938S, PLX610866S, PLX612123S, PLX608086S, PLX608118S, PLX609410S, PLX610864S, PLX610961S, PLX610967S, PLX611934S, PLX611951S, PLX614024S, PLX614073S, PLX608054S, PLX605322S, PLX614114S, PLX607228S, PLX607330S, PLX607943S, PLX613085S, PLX609803S, PLX607928S, PLX605323S, PLX607310S, PLX607333S, PLX606750S, PLX608915S, PLX608983S, PLX609494S, PLX610736S, PLX610740S, PLX610953S, PLX610949S, PLX612097S, PLX608914S, PLX607332S, PLX607785S, PLX607788S, PLX609693S, PLX609858S, PLX608510S, PLX607200S, PLX610731S, PLX606698S, PLX607506S, PLX610276S, PLX606134S, PLX605235S, PLX606368S, PLX612749S, PLX607386S, PLX606748S, PLX610920S, PLX614233S, PLX607508S, PLX612649S, PLX612650S, PLX608980S, PLX609862S, PLX604556S, PLX610980S, PLX607566S, PLX608469S, PLX610900S, PLX606141S, PLX608096S, PLX608113S, PLX609491S, PLX609859S, PLX611893S, PLX611897S, PLX608092S, PLX607939S, PLX608401S, PLX608994S, PLX606341S, PLX609486S, PLX608954S, PLX604652S, PLX605335S, PLX605336S, PLX606958S, PLX610935S, PLX612860S, PLX609834S, PLX607784S, PLX607327S, PLX607665S, PLX609533S, PLX610317S, PLX611000S, PLX614302S, PLX605298S, PLX608179S, PLX606993S, PLX607676S, PLX60900…
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-1806-2023 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.