ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1709-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; 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 DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1709-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1709-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1709-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1709-2023
      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 00643169720411, Lot Serial Numbers: BWG208720H, BWG208284H, BWG208405H, BWG208608H, BWG208700H, BWG208763H, BWG208301H, BWG208376H, BWG208406H, BWG208412H, BWG208520H, BWG208539H, BWG208652H, BWG208716H, BWG208296H, BWG208340H, BWG208484H, BWG208220H, BWG208234H, BWG208641H, BWG208702H, BWG208758H, BWG208430H, BWG208206H, BWG208215H, BWG208561H, BWG208216H, BWG208705H, BWG208502H, BWG208221H, BWG208236H, BWG208488H, BWG208403H, BWG208312H, BWG208557H, BWG208335H, BWG208530H, BWG208634H, BWG208745H, BWG208746H, BWG208249H, BWG208654H, BWG208291H, BWG208515H, BWG208596H, BWG208636H, BWG208637H, BWG208730H, BWG208757H, BWG208213H, BWG208347H, BWG208597H, BWG208605H, BWG208692H, BWG208514H, BWG208640H, BWG208326H, BWG208499H, BWG208223H, BWG208491H, BWG208541H, BWG208573H, BWG208304H, BWG208323H, BWG208345H, BWG208370H, BWG208672H, BWG208250H, BWG208270H, BWG208346H, BWG208389H, BWG208482H, BWG208494H, BWG208495H, BWG208497H, BWG208498H, BWG208521H, BWG208547H, BWG208396H, BWG208799H, BWG208224H, BWG208225H, BWG208258H, BWG208261H, BWG208272H, BWG208275H, BWG208276H, BWG208279H, BWG208328H, BWG208337H, BWG208343H, BWG208357H, BWG208360H, BWG208361H, BWG208416H, BWG208417H, BWG208422H, BWG208423H, BWG208462H, BWG208464H, BWG208465H, BWG208468H, BWG208469H, BWG208470H, BWG208471H, BWG208472H, BWG208581H, BWG208583H, BWG208584H, BWG208585H, BWG208586H, BWG208587H, BWG208588H, BWG208639H, BWG208647H, BWG208649H, BWG208660H, BWG208661H, BWG208663H, BWG208664H, BWG208668H, BWG208674H, BWG208770H, BWG208774H, BWG208775H, BWG208777H, BWG208778H, BWG208779H, BWG208780H, BWG208781H, BWG208421H, BWG208452H, BWG208486H, BWG208493H, BWG208504H, BWG208571H, BWG208614H, BWG208543H, BWG208549H, BWG208681H, BWG208544H, BWG208002H, BWG208212H, BWG208359H, BWG208373H, BWG208413H, BWG208447H, BWG208232H, BWG208252H, BWG208205H, BWG208386H, BWG208540H, BWG208575H, BWG208631H, BWG208769H, BWG208306H, BWG208768H, BWG208273H, BWG208689H, BWG208742H, BWG208798H, BWG208227H, BWG208796H, BWG…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1709-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1709-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; 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 00643169720411, Lot Serial Numbers: BWG208720H, BWG208284H, BWG208405H, BWG208608H, BWG208700H, BWG208763H, BWG208301H, BWG208376H, BWG208406H, BWG208412H, BWG208520H, BWG208539H, BWG208652H, BWG208716H, BWG208296H, BWG208340H, BWG208484H, BWG208220H, BWG208234H, BWG208641H, BWG208702H, BWG208758H, BWG208430H, BWG208206H, BWG208215H, BWG208561H, BWG208216H, BWG208705H, BWG208502H, BWG208221H, BWG208236H, BWG208488H, BWG208403H, BWG208312H, BWG208557H, BWG208335H, BWG208530H, BWG208634H, BWG208745H, BWG208746H, BWG208249H, BWG208654H, BWG208291H, BWG208515H, BWG208596H, BWG208636H, BWG208637H, BWG208730H, BWG208757H, BWG208213H, BWG208347H, BWG208597H, BWG208605H, BWG208692H, BWG208514H, BWG208640H, BWG208326H, BWG208499H, BWG208223H, BWG208491H, BWG208541H, BWG208573H, BWG208304H, BWG208323H, BWG208345H, BWG208370H, BWG208672H, BWG208250H, BWG208270H, BWG208346H, BWG208389H, BWG208482H, BWG208494H, BWG208495H, BWG208497H, BWG208498H, BWG208521H, BWG208547H, BWG208396H, BWG208799H, BWG208224H, BWG208225H, BWG208258H, BWG208261H, BWG208272H, BWG208275H, BWG208276H, BWG208279H, BWG208328H, BWG208337H, BWG208343H, BWG208357H, BWG208360H, BWG208361H, BWG208416H, BWG208417H, BWG208422H, BWG208423H, BWG208462H, BWG208464H, BWG208465H, BWG208468H, BWG208469H, BWG208470H, BWG208471H, BWG208472H, BWG208581H, BWG208583H, BWG…
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-1709-2023 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.