ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1710-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; 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-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1710-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1710-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1710-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1710-2023
      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 00643169720381, Lot Serial Numbers: BWF206541H, BWF206448H, BWF206403H, BWF206382H, BWF206552H, BWF206320H, BWF206323H, BWF206420H, BWF206376H, BWF206458H, BWF206459H, BWF206430H, BWF206453H, BWF206359H, BWF206478H, BWF206333H, BWF206365H, BWF206370H, BWF206557H, BWF206599H, BWF206607H, BWF206551H, BWF206367H, BWF206396H, BWF206421H, BWF206554H, BWF206355H, BWF206461H, BWF206604H, BWF206371H, BWF206373H, BWF206374H, BWF206378H, BWF206380H, BWF206381H, BWF206383H, BWF206387H, BWF206388H, BWF206390H, BWF206449H, BWF206473H, BWF206474H, BWF206475H, BWF206500H, BWF206526H, BWF206527H, BWF206528H, BWF206529H, BWF206535H, BWF206563H, BWF206565H, BWF206567H, BWF206568H, BWF206573H, BWF206574H, BWF206575H, BWF206597H, BWF206598H, BWF206175H, BWF206419H, BWF206327H, BWF206491H, BWF206496H, BWF206401H, BWF206321H, BWF206334H, BWF206338H, BWF206344H, BWF206432H, BWF206470H, BWF206489H, BWF206507H, BWF206558H, BWF206577H, BWF206583H, BWF206570H, BWF206581H, BWF206342H, BWF206410H, BWF206492H, BWF206417H, BWF206424H, BWF206476H, BWF206539H, BWF206580H, BWF206485H, BWF206608H, BWF206601H, BWF206317H, BWF206384H, BWF206395H, BWF206490H, BWF206585H, BWF206590H, BWF206322H, BWF206431H, BWF206443H, BWF206463H, BWF206484H, BWF206487H, BWF206497H, BWF206502H, BWF206505H, BWF206534H, BWF206553H, BWF206569H, BWF206571H, BWF206415H, BWF206451H, BWF206452H, BWF206544H, BWF206546H, BWF206460H, BWF206360H, BWF206440H, BWF206462H, BWF206340H, BWF206435H, BWF206510H, BWF206495H, BWF206375H, BWF206405H, BWF206418H, BWF206454H, BWF206465H, BWF206488H, BWF206358H, BWF206353H, BWF206397H, BWF206582H, BWF206176H, BWF206456H, BWF206589H, BWF206412H, BWF206369H, BWF206394H, BWF206426H, BWF206398H, BWF206578H, BWF206425H, BWF206318H, BWF206402H, BWF206584H, BWF206357H, BWF206400H, BWF206409H, BWF206341H, BWF206428H, BWF206392H, BWF206393H, BWF206416H, BWF206427H, BWF206437H, BWF206441H, BWF206518H, BWF206530H, BWF206533H, BWF206345H, BWF206455H, BWF206457H, BWF206594H, BWF206602H, BWF206548H, BWF…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1710-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1710-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; 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 00643169720381, Lot Serial Numbers: BWF206541H, BWF206448H, BWF206403H, BWF206382H, BWF206552H, BWF206320H, BWF206323H, BWF206420H, BWF206376H, BWF206458H, BWF206459H, BWF206430H, BWF206453H, BWF206359H, BWF206478H, BWF206333H, BWF206365H, BWF206370H, BWF206557H, BWF206599H, BWF206607H, BWF206551H, BWF206367H, BWF206396H, BWF206421H, BWF206554H, BWF206355H, BWF206461H, BWF206604H, BWF206371H, BWF206373H, BWF206374H, BWF206378H, BWF206380H, BWF206381H, BWF206383H, BWF206387H, BWF206388H, BWF206390H, BWF206449H, BWF206473H, BWF206474H, BWF206475H, BWF206500H, BWF206526H, BWF206527H, BWF206528H, BWF206529H, BWF206535H, BWF206563H, BWF206565H, BWF206567H, BWF206568H, BWF206573H, BWF206574H, BWF206575H, BWF206597H, BWF206598H, BWF206175H, BWF206419H, BWF206327H, BWF206491H, BWF206496H, BWF206401H, BWF206321H, BWF206334H, BWF206338H, BWF206344H, BWF206432H, BWF206470H, BWF206489H, BWF206507H, BWF206558H, BWF206577H, BWF206583H, BWF206570H, BWF206581H, BWF206342H, BWF206410H, BWF206492H, BWF206417H, BWF206424H, BWF206476H, BWF206539H, BWF206580H, BWF206485H, BWF206608H, BWF206601H, BWF206317H, BWF206384H, BWF206395H, BWF206490H, BWF206585H, BWF206590H, BWF206322H, BWF206431H, BWF206443H, BWF206463H, BWF206484H, BWF206487H, BWF206497H, BWF206502H, BWF206505H, BWF206534H, BWF206553H, BWF206569H, BWF206571H, BWF206415H, BWF…
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-1710-2023 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.