ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1716-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; 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 DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1716-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1716-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1716-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1716-2023
      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 00643169720527, Lot Serial Numbers: PHZ203294H, PHZ204099H, PHZ202880H, PHZ202731H, PHZ203576H, PHZ203873H, PHZ202558H, PHZ202949H, PHZ203163H, PHZ204430H, PHZ203645H, PHZ204171H, PHZ204583H, PHZ204585H, PHZ204589H, PHZ204600H, PHZ204629H, PHZ204676H, PHZ204879H, PHZ204932H, PHZ204991H, PHZ205067H, PHZ205076H, PHZ205168H, PHZ205219H, PHZ205254H, PHZ205303H, PHZ204750H, PHZ202687H, PHZ203913H, PHZ203379H, PHZ203419H, PHZ203421H, PHZ203422H, PHZ203423H, PHZ203425H, PHZ203426H, PHZ203427H, PHZ203435H, PHZ203798H, PHZ203805H, PHZ203808H, PHZ203809H, PHZ203811H, PHZ203816H, PHZ203819H, PHZ203820H, PHZ203822H, PHZ203828H, PHZ203829H, PHZ203830H, PHZ203831H, PHZ204440H, PHZ204442H, PHZ204444H, PHZ204445H, PHZ204446H, PHZ204447H, PHZ204448H, PHZ204449H, PHZ204451H, PHZ205205H, PHZ205206H, PHZ205207H, PHZ205208H, PHZ205209H, PHZ205210H, PHZ205211H, PHZ205213H, PHZ205216H, PHZ205244H, PHZ202741H, PHZ203347H, PHZ202606H, PHZ202985H, PHZ203618H, PHZ204288H, PHZ205146H, PHZ202758H, PHZ202806H, PHZ203203H, PHZ203252H, PHZ203313H, PHZ203319H, PHZ203321H, PHZ203702H, PHZ203771H, PHZ204242H, PHZ204399H, PHZ204603H, PHZ204771H, PHZ204983H, PHZ204987H, PHZ205118H, PHZ205301H, PHZ205302H, PHZ202654H, PHZ202763H, PHZ202764H, PHZ203019H, PHZ203220H, PHZ203333H, PHZ203420H, PHZ203573H, PHZ204247H, PHZ204394H, PHZ204534H, PHZ204747H, PHZ204878H, PHZ204962H, PHZ205396H, PHZ202796H, PHZ202886H, PHZ203577H, PHZ203611H, PHZ202965H, PHZ203867H, PHZ205448H, PHZ204468H, PHZ203789H, PHZ203249H, PHZ203643H, PHZ204150H, PHZ204845H, PHZ205097H, PHZ202533H, PHZ202641H, PHZ202773H, PHZ203008H, PHZ203012H, PHZ203077H, PHZ203161H, PHZ203234H, PHZ203266H, PHZ203511H, PHZ203624H, PHZ203717H, PHZ203720H, PHZ203877H, PHZ203918H, PHZ203976H, PHZ204001H, PHZ204124H, PHZ204488H, PHZ205160H, PHZ205428H, PHZ203914H, PHZ204349H, PHZ204368H, PHZ204406H, PHZ204570H, PHZ205131H, PHZ205278H, PHZ205306H, PHZ205311H, PHZ205313H, PHZ202961H, PHZ203195H, PHZ203308H, PHZ203569H, PHZ203621H, PHZ203662H, PHZ203930H, PHZ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1716-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1716-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; 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 00643169720527, Lot Serial Numbers: PHZ203294H, PHZ204099H, PHZ202880H, PHZ202731H, PHZ203576H, PHZ203873H, PHZ202558H, PHZ202949H, PHZ203163H, PHZ204430H, PHZ203645H, PHZ204171H, PHZ204583H, PHZ204585H, PHZ204589H, PHZ204600H, PHZ204629H, PHZ204676H, PHZ204879H, PHZ204932H, PHZ204991H, PHZ205067H, PHZ205076H, PHZ205168H, PHZ205219H, PHZ205254H, PHZ205303H, PHZ204750H, PHZ202687H, PHZ203913H, PHZ203379H, PHZ203419H, PHZ203421H, PHZ203422H, PHZ203423H, PHZ203425H, PHZ203426H, PHZ203427H, PHZ203435H, PHZ203798H, PHZ203805H, PHZ203808H, PHZ203809H, PHZ203811H, PHZ203816H, PHZ203819H, PHZ203820H, PHZ203822H, PHZ203828H, PHZ203829H, PHZ203830H, PHZ203831H, PHZ204440H, PHZ204442H, PHZ204444H, PHZ204445H, PHZ204446H, PHZ204447H, PHZ204448H, PHZ204449H, PHZ204451H, PHZ205205H, PHZ205206H, PHZ205207H, PHZ205208H, PHZ205209H, PHZ205210H, PHZ205211H, PHZ205213H, PHZ205216H, PHZ205244H, PHZ202741H, PHZ203347H, PHZ202606H, PHZ202985H, PHZ203618H, PHZ204288H, PHZ205146H, PHZ202758H, PHZ202806H, PHZ203203H, PHZ203252H, PHZ203313H, PHZ203319H, PHZ203321H, PHZ203702H, PHZ203771H, PHZ204242H, PHZ204399H, PHZ204603H, PHZ204771H, PHZ204983H, PHZ204987H, PHZ205118H, PHZ205301H, PHZ205302H, PHZ202654H, PHZ202763H, PHZ202764H, PHZ203019H, PHZ203220H, PHZ203333H, PHZ203420H, PHZ203573H, PHZ204247H, PHZ204394H, PHZ204534H, PHZ204747H…
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-1716-2023 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.