ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1715-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; 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 DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1715-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1715-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1715-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1715-2023
      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 00643169837737, Lot Serial Numbers: CWC602314S, CWC602130S, CWC601890S, CWC607466S, CWC602236S, CWC602359S, CWC608108S, CWC607103S, CWC601544S, CWC601546S, CWC605273S, CWC602965S, CWC604941S, CWC605039S, CWC601687S, CWC601688S, CWC602560S, CWC602845S, CWC603176S, CWC603372S, CWC603584S, CWC603596S, CWC603780S, CWC603826S, CWC603862S, CWC604054S, CWC604145S, CWC604909S, CWC605061S, CWC605800S, CWC607271S, CWC607272S, CWC607475S, CWC608775S, CWC608917S, CWC608956S, CWC608480S, CWC608488S, CWC603831S, CWC604086S, CWC604166S, CWC604240S, CWC604391S, CWC604670S, CWC604681S, CWC604684S, CWC604846S, CWC604847S, CWC605090S, CWC605290S, CWC605410S, CWC605411S, CWC605588S, CWC605600S, CWC605863S, CWC605864S, CWC605867S, CWC605876S, CWC605988S, CWC605989S, CWC606354S, CWC606357S, CWC606358S, CWC606521S, CWC606523S, CWC606525S, CWC606527S, CWC606528S, CWC606529S, CWC606531S, CWC606939S, CWC606942S, CWC607001S, CWC607022S, CWC607619S, CWC607630S, CWC607631S, CWC607635S, CWC604643S, CWC605193S, CWC605519S, CWC605785S, CWC606634S, CWC606664S, CWC606904S, CWC606912S, CWC607065S, CWC605675S, CWC605681S, CWC606623S, CWC606625S, CWC606627S, CWC606630S, CWC606675S, CWC606903S, CWC606905S, CWC606907S, CWC606622S, CWC602509S, CWC602834S, CWC602842S, CWC602870S, CWC602894S, CWC603092S, CWC603787S, CWC606427S, CWC606910S, CWC607057S, CWC607062S, CWC607063S, CWC607068S, CWC607070S, CWC607078S, CWC607079S, CWC607566S, CWC607748S, CWC607752S, CWC601658S, CWC602650S, CWC602956S, CWC603748S, CWC608483S, CWC603460S, CWC602647S, CWC603000S, CWC603458S, CWC603477S, CWC603736S, CWC606655S, CWC606917S, CWC606921S, CWC609069S, CWC603455S, CWC603767S, CWC607083S, CWC608486S, CWC607056S, CWC603090S, CWC603091S, CWC603454S, CWC603459S, CWC605858S, CWC606922S, CWC606927S, CWC604162S, CWC602895S, CWC606633S, CWC606662S, CWC607088S, CWC607090S, CWC607115S, CWC607515S, CWC607743S, CWC607757S, CWC602893S, CWC603461S, CWC604649S, CWC605793S, CWC606643S, CWC606875S, CWC605902S, CWC606944S, CWC607753S, CWC…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1715-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1715-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; 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 00643169837737, Lot Serial Numbers: CWC602314S, CWC602130S, CWC601890S, CWC607466S, CWC602236S, CWC602359S, CWC608108S, CWC607103S, CWC601544S, CWC601546S, CWC605273S, CWC602965S, CWC604941S, CWC605039S, CWC601687S, CWC601688S, CWC602560S, CWC602845S, CWC603176S, CWC603372S, CWC603584S, CWC603596S, CWC603780S, CWC603826S, CWC603862S, CWC604054S, CWC604145S, CWC604909S, CWC605061S, CWC605800S, CWC607271S, CWC607272S, CWC607475S, CWC608775S, CWC608917S, CWC608956S, CWC608480S, CWC608488S, CWC603831S, CWC604086S, CWC604166S, CWC604240S, CWC604391S, CWC604670S, CWC604681S, CWC604684S, CWC604846S, CWC604847S, CWC605090S, CWC605290S, CWC605410S, CWC605411S, CWC605588S, CWC605600S, CWC605863S, CWC605864S, CWC605867S, CWC605876S, CWC605988S, CWC605989S, CWC606354S, CWC606357S, CWC606358S, CWC606521S, CWC606523S, CWC606525S, CWC606527S, CWC606528S, CWC606529S, CWC606531S, CWC606939S, CWC606942S, CWC607001S, CWC607022S, CWC607619S, CWC607630S, CWC607631S, CWC607635S, CWC604643S, CWC605193S, CWC605519S, CWC605785S, CWC606634S, CWC606664S, CWC606904S, CWC606912S, CWC607065S, CWC605675S, CWC605681S, CWC606623S, CWC606625S, CWC606627S, CWC606630S, CWC606675S, CWC606903S, CWC606905S, CWC606907S, CWC606622S, CWC602509S, CWC602834S, CWC602842S, CWC602870S, CWC602894S, CWC603092S, CWC603787S, CWC606427S, CWC606910S, CWC607057S, C…
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-1715-2023 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.