ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1799-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; 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 DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1799-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1799-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1799-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1799-2023
      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 00643169720473, Lot Serial Numbers: BWM204909H, BWM204998H, BWM205011H, BWM205017H, BWM204963H, BWM204962H, BWM205000H, BWM204927H, BWM204911H, BWM204921H, BWM204926H, BWM204932H, BWM204936H, BWM204944H, BWM204954H, BWM204955H, BWM204959H, BWM204983H, BWM204984H, BWM204989H, BWM204990H, BWM205004H, BWM205006H, BWM205008H, BWM205013H, BWM205014H, BWM205015H, BWM205016H, BWM205019H, BWM205021H, BWM205023H, BWM205024H, BWM205027H, BWM205033H, BWM205036H, BWM205037H, BWM204792H, BWM204938H, BWM204961H, BWM204916H, BWM204922H, BWM204950H, BWM204957H, BWM204993H, BWM205009H, BWM204923H, BWM204924H, BWM204987H, BWM205028H, BWM204956H, BWM204953H, BWM204789H, BWM204790H, BWM204935H, BWM204905H, BWM204906H, BWM204960H, BWM204980H, BWM204991H, BWM204914H, BWM204933H, BWM204985H, BWM204997H, BWM204948H, BWM204971H, BWM204992H, BWM205007H, BWM205034H, BWM204793H, BWM204904H, BWM204910H, BWM204970H, BWM204977H, BWM204982H, BWM204928H, BWM204930H, BWM205002H, BWM205035H, BWM204967H, BWM204974H, BWM204966H, BWM204978H, BWM204946H; GTIN 00643169720480, Lot Serial Numbers: BWM606690S, BWM606723S, BWM608186S, BWM607102S, BWM606494S, BWM607083S, BWM606927S, BWM607005S, BWM607272S, BWM606644S, BWM606971S, BWM607093S, BWM606920S, BWM606879S, BWM606579S, BWM606943S, BWM607045S, BWM607027S, BWM606500S, BWM606861S, BWM606975S, BWM607158S, BWM606473S, BWM608141S, BWM606616S, BWM606706S, BWM606946S, BWM607013S, BWM606719S, BWM606720S, BWM607007S, BWM607154S, BWM607170S, BWM607176S, BWM608142S, BWM608146S, BWM608951S, BWM606685S, BWM606728S, BWM606911S, BWM606921S, BWM606930S, BWM606931S, BWM606932S, BWM606986S, BWM607014S, BWM607407S, BWM606903S, BWM607018S, BWM606681S, BWM606907S, BWM607024S, BWM606178S, BWM606475S, BWM606478S, BWM606852S, BWM606853S, BWM607114S, BWM607119S, BWM606686S, BWM606963S, BWM607173S, BWM607175S, BWM607264S, BWM606863S, BWM606913S, BWM606914S, BWM606915S, BWM606916S, BWM606934S, BWM607094S, BWM606864S, BWM606987S, BWM607156S, BWM607019S, BWM606929S, BWM606627S…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1799-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1799-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; 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 00643169720473, Lot Serial Numbers: BWM204909H, BWM204998H, BWM205011H, BWM205017H, BWM204963H, BWM204962H, BWM205000H, BWM204927H, BWM204911H, BWM204921H, BWM204926H, BWM204932H, BWM204936H, BWM204944H, BWM204954H, BWM204955H, BWM204959H, BWM204983H, BWM204984H, BWM204989H, BWM204990H, BWM205004H, BWM205006H, BWM205008H, BWM205013H, BWM205014H, BWM205015H, BWM205016H, BWM205019H, BWM205021H, BWM205023H, BWM205024H, BWM205027H, BWM205033H, BWM205036H, BWM205037H, BWM204792H, BWM204938H, BWM204961H, BWM204916H, BWM204922H, BWM204950H, BWM204957H, BWM204993H, BWM205009H, BWM204923H, BWM204924H, BWM204987H, BWM205028H, BWM204956H, BWM204953H, BWM204789H, BWM204790H, BWM204935H, BWM204905H, BWM204906H, BWM204960H, BWM204980H, BWM204991H, BWM204914H, BWM204933H, BWM204985H, BWM204997H, BWM204948H, BWM204971H, BWM204992H, BWM205007H, BWM205034H, BWM204793H, BWM204904H, BWM204910H, BWM204970H, BWM204977H, BWM204982H, BWM204928H, BWM204930H, BWM205002H, BWM205035H, BWM204967H, BWM204974H, BWM204966H, BWM204978H, BWM204946H; GTIN 00643169720480, Lot Serial Numbers: BWM606690S, BWM606723S, BWM608186S, BWM607102S, BWM606494S, BWM607083S, BWM606927S, BWM607005S, BWM607272S, BWM606644S, BWM606971S, BWM607093S, BWM606920S, BWM606879S, BWM606579S, BWM606943S, BWM607045S, BWM607027S, BWM606500S, BWM606861S, BWM606975S, BWM607158S…
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-1799-2023 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.