ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1811-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; 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 DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1811-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1811-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1811-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1811-2023
      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 00643169720565, Lot Serial Numbers: PLZ611718S, PLZ611713S, PLZ611719S, PLZ613233S, PLZ613240S, PLZ613268S, PLZ613269S, PLZ613270S, PLZ610634S, PLZ612616S, PLZ613234S, PLZ610657S, PLZ611892S, PLZ610319S, PLZ610320S, PLZ610622S, PLZ610625S, PLZ610626S, PLZ610627S, PLZ610631S, PLZ610670S, PLZ610671S, PLZ610672S, PLZ610988S, PLZ610990S, PLZ610992S, PLZ611154S, PLZ611155S, PLZ611159S, PLZ611202S, PLZ611643S, PLZ611644S, PLZ611645S, PLZ611815S, PLZ611819S, PLZ611822S, PLZ611889S, PLZ611890S, PLZ611891S, PLZ610001S, PLZ611744S, PLZ610666S, PLZ613301S, PLZ613302S, PLZ611722S, PLZ611738S, PLZ611741S, PLZ611923S, PLZ612176S, PLZ613231S, PLZ613236S, PLZ613237S, PLZ613250S, PLZ613282S, PLZ613288S, PLZ613298S, PLZ611726S, PLZ611728S, PLZ613246S, PLZ613247S, PLZ613248S, PLZ610991S, PLZ611759S, PLZ611768S, PLZ610684S, PLZ610986S, PLZ610515S, PLZ610989S, PLZ611145S, PLZ611716S, PLZ611116S, PLZ611707S, PLZ611714S, PLZ610471S, PLZ610996S, PLZ613221S, PLZ613223S, PLZ613224S, PLZ613225S, PLZ613226S, PLZ613227S, PLZ613228S, PLZ610496S, PLZ611729S, PLZ613235S, PLZ613279S, PLZ613296S, PLZ610318S, PLZ610326S, PLZ610352S, PLZ610458S, PLZ610459S, PLZ611004S, PLZ611730S, PLZ611922S, PLZ612232S, PLZ612654S, PLZ612815S, PLZ613229S, PLZ613230S, PLZ613238S, PLZ613239S, PLZ613244S, PLZ613245S, PLZ613265S, PLZ613271S, PLZ613274S, PLZ613275S, PLZ613276S, PLZ613283S, PLZ613285S, PLZ613287S, PLZ613293S, PLZ613294S, PLZ613309S, PLZ613291S, PLZ610995S, PLZ611747S, PLZ611748S, PLZ611920S, PLZ611921S, PLZ613251S, PLZ613277S, PLZ613278S, PLZ613289S, PLZ613290S, PLZ613242S, PLZ612824S, PLZ613264S, PLZ613280S, PLZ613292S, PLZ613297S, PLZ613303S, PLZ611919S, PLZ611755S, PLZ611778S, PLZ611752S, PLZ610985S, PLZ613281S, PLZ610477S, PLZ610478S, PLZ610479S, PLZ610480S, PLZ610481S, PLZ610482S, PLZ610483S, PLZ610484S, PLZ610485S, PLZ610486S, PLZ610487S, PLZ610488S, PLZ610489S, PLZ610490S, PLZ610491S, PLZ610492S, PLZ610493S, PLZ610494S, PLZ610495S, PLZ610504S, PLZ610505S, PLZ610506S, PLZ610507S, PLZ610508S, PLZ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1811-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1811-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; 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 00643169720565, Lot Serial Numbers: PLZ611718S, PLZ611713S, PLZ611719S, PLZ613233S, PLZ613240S, PLZ613268S, PLZ613269S, PLZ613270S, PLZ610634S, PLZ612616S, PLZ613234S, PLZ610657S, PLZ611892S, PLZ610319S, PLZ610320S, PLZ610622S, PLZ610625S, PLZ610626S, PLZ610627S, PLZ610631S, PLZ610670S, PLZ610671S, PLZ610672S, PLZ610988S, PLZ610990S, PLZ610992S, PLZ611154S, PLZ611155S, PLZ611159S, PLZ611202S, PLZ611643S, PLZ611644S, PLZ611645S, PLZ611815S, PLZ611819S, PLZ611822S, PLZ611889S, PLZ611890S, PLZ611891S, PLZ610001S, PLZ611744S, PLZ610666S, PLZ613301S, PLZ613302S, PLZ611722S, PLZ611738S, PLZ611741S, PLZ611923S, PLZ612176S, PLZ613231S, PLZ613236S, PLZ613237S, PLZ613250S, PLZ613282S, PLZ613288S, PLZ613298S, PLZ611726S, PLZ611728S, PLZ613246S, PLZ613247S, PLZ613248S, PLZ610991S, PLZ611759S, PLZ611768S, PLZ610684S, PLZ610986S, PLZ610515S, PLZ610989S, PLZ611145S, PLZ611716S, PLZ611116S, PLZ611707S, PLZ611714S, PLZ610471S, PLZ610996S, PLZ613221S, PLZ613223S, PLZ613224S, PLZ613225S, PLZ613226S, PLZ613227S, PLZ613228S, PLZ610496S, PLZ611729S, PLZ613235S, PLZ613279S, PLZ613296S, PLZ610318S, PLZ610326S, PLZ610352S, PLZ610458S, PLZ610459S, PLZ611004S, PLZ611730S, PLZ611922S, PLZ612232S, PLZ612654S, PLZ612815S, PLZ613229S, PLZ613230S, PLZ613238S, PLZ613239S, PLZ613244S, PLZ613245S, PLZ613265S, PLZ613271S, PLZ613274S, PLZ613275S, PL…
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-1811-2023 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.