ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1720-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; 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 DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1720-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1720-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1720-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1720-2023
      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 00763000001582, Lot Serial Numbers: CWT605432S, CWT600264S, CWT607420S, CWT607213S, CWT607463S, CWT607388S, CWT607425S, CWT607374S, CWT607359S, CWT601622S, CWT603529S, CWT605876S, CWT605723S, CWT604657S, CWT604666S, CWT605105S, CWT605034S, CWT608381S, CWT608194S, CWT606083S, CWT604306S, CWT606483S, CWT607258S, CWT606731S, CWT605978S, CWT607015S, CWT606443S, CWT607932S, CWT608011S, CWT607139S, CWT606486S, CWT605678S, CWT607017S, CWT607943S, CWT608012S, CWT606735S, CWT606736S, CWT606738S, CWT606739S, CWT606741S, CWT606742S, CWT606743S, CWT606744S, CWT606745S, CWT606746S, CWT606747S, CWT606748S, CWT606749S, CWT606750S, CWT603376S, CWT607308S, CWT602883S, CWT603530S, CWT604069S, CWT604509S, CWT604647S, CWT604878S, CWT605689S, CWT605944S, CWT606036S, CWT600803S, CWT601014S, CWT601028S, CWT601179S, CWT601231S, CWT601422S, CWT602980S, CWT602981S, CWT603019S, CWT603216S, CWT603319S, CWT603320S, CWT604576S, CWT605154S, CWT600275S, CWT601002S, CWT601180S, CWT601388S, CWT601407S, CWT601417S, CWT601516S, CWT601527S, CWT601652S, CWT601681S, CWT601719S, CWT601946S, CWT602082S, CWT602826S, CWT602908S, CWT602909S, CWT603061S, CWT603503S, CWT603506S, CWT603642S, CWT604058S, CWT604226S, CWT604247S, CWT604526S, CWT604690S, CWT604887S, CWT605146S, CWT605366S, CWT605914S, CWT605945S, CWT605947S, CWT606707S, CWT606841S, CWT607734S, CWT607765S, CWT606600S, CWT606712S, CWT608010S, CWT603422S, CWT603615S, CWT604547S, CWT600386S, CWT601108S, CWT601852S, CWT600660S, CWT600729S, CWT601033S, CWT601672S, CWT601941S, CWT602192S, CWT603089S, CWT603730S, CWT603989S, CWT604890S, CWT605015S, CWT605144S, CWT606466S, CWT607741S, CWT607883S, CWT601876S, CWT602470S, CWT603447S, CWT604625S, CWT606476S, CWT606554S, CWT604073S, CWT604112S, CWT604113S, CWT604302S, CWT604305S, CWT604888S, CWT604930S, CWT605255S, CWT600976S, CWT601132S, CWT601228S, CWT604277S, CWT606797S, CWT600337S, CWT601044S, CWT601072S, CWT601532S, CWT601775S, CWT603173S, CWT602968S, CWT600809S, CWT604144S, CWT601814S, CWT601815S, CWT…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1720-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1720-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; 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 00763000001582, Lot Serial Numbers: CWT605432S, CWT600264S, CWT607420S, CWT607213S, CWT607463S, CWT607388S, CWT607425S, CWT607374S, CWT607359S, CWT601622S, CWT603529S, CWT605876S, CWT605723S, CWT604657S, CWT604666S, CWT605105S, CWT605034S, CWT608381S, CWT608194S, CWT606083S, CWT604306S, CWT606483S, CWT607258S, CWT606731S, CWT605978S, CWT607015S, CWT606443S, CWT607932S, CWT608011S, CWT607139S, CWT606486S, CWT605678S, CWT607017S, CWT607943S, CWT608012S, CWT606735S, CWT606736S, CWT606738S, CWT606739S, CWT606741S, CWT606742S, CWT606743S, CWT606744S, CWT606745S, CWT606746S, CWT606747S, CWT606748S, CWT606749S, CWT606750S, CWT603376S, CWT607308S, CWT602883S, CWT603530S, CWT604069S, CWT604509S, CWT604647S, CWT604878S, CWT605689S, CWT605944S, CWT606036S, CWT600803S, CWT601014S, CWT601028S, CWT601179S, CWT601231S, CWT601422S, CWT602980S, CWT602981S, CWT603019S, CWT603216S, CWT603319S, CWT603320S, CWT604576S, CWT605154S, CWT600275S, CWT601002S, CWT601180S, CWT601388S, CWT601407S, CWT601417S, CWT601516S, CWT601527S, CWT601652S, CWT601681S, CWT601719S, CWT601946S, CWT602082S, CWT602826S, CWT602908S, CWT602909S, CWT603061S, CWT603503S, CWT603506S, CWT603642S, CWT604058S, CWT604226S, CWT604247S, CWT604526S, CWT604690S, CWT604887S, CWT605146S, CWT605366S, CWT605914S, CWT605945S, CWT605947S, CWT606707S, CWT606841S, CWT607734S, CWT607765S, CW…
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-1720-2023 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.