ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1719-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; 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 DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1719-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1719-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1719-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1719-2023
      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 00763000001568, Lot Serial Numbers: CWS603181S, CWS601328S, CWS601620S, CWS601980S, CWS602302S, CWS602482S, CWS602880S, CWS602742S, CWS602559S, CWS602607S, CWS602433S, CWS602957S, CWS601056S, CWS601348S, CWS601807S, CWS602219S, CWS602422S, CWS602474S, CWS601519S, CWS601425S, CWS601296S, CWS602918S, CWS600483S, CWS600490S, CWS600494S, CWS600607S, CWS600960S, CWS601001S, CWS601199S, CWS601460S, CWS601594S, CWS601704S, CWS601713S, CWS601790S, CWS600422S, CWS600502S, CWS600125S, CWS600132S, CWS600342S, CWS600571S, CWS601791S, CWS600172S, CWS600318S, CWS600423S, CWS600453S, CWS600464S, CWS600686S, CWS601122S, CWS601155S, CWS601445S, CWS601981S, CWS601465S, CWS601628S, CWS600445S, CWS602676S, CWS600945S, CWS600142S, CWS600147S, CWS600178S, CWS600551S, CWS600557S, CWS600770S, CWS600996S, CWS601094S, CWS601323S, CWS601966S, CWS602181S, CWS602556S, CWS602618S, CWS602879S, CWS601541S, CWS601542S, CWS601203S, CWS601374S, CWS602139S, CWS600458S, CWS600102S, CWS600781S, CWS600759S, CWS600764S, CWS600765S, CWS600805S, CWS600806S, CWS600807S, CWS601024S, CWS601111S, CWS601201S, CWS601718S, CWS601979S, CWS602753S, CWS600731S, CWS601304S, CWS601780S, CWS602108S, CWS602214S, CWS601240S, CWS602411S, CWS602889S, CWS600108S, CWS601150S, CWS602620S, CWS601627S, CWS600523S, CWS600244S, CWS600631S, CWS600234S, CWS600315S, CWS600412S, CWS600432S, CWS600699S, CWS600804S, CWS601098S, CWS601210S, CWS601219S, CWS601223S, CWS601225S, CWS601309S, CWS601313S, CWS601431S, CWS601434S, CWS601723S, CWS601904S, CWS602455S, CWS602456S, CWS602749S, CWS600498S, CWS600782S, CWS601329S, CWS600180S, CWS600503S, CWS601216S, CWS601586S, CWS601971S, CWS602609S, CWS602881S, CWS600255S, CWS600884S, CWS600268S, CWS600309S, CWS600767S, CWS600987S, CWS601050S, CWS601310S, CWS601314S, CWS601609S, CWS602121S, CWS601543S, CWS601593S, CWS602105S, CWS601562S, CWS601563S, CWS602067S, CWS601744S, CWS600344S, CWS601389S, CWS601393S, CWS601433S, CWS601438S, CWS601442S, CWS601447S, CWS601510S, CWS601571S, CWS601607S, CWS…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1719-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1719-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; 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 00763000001568, Lot Serial Numbers: CWS603181S, CWS601328S, CWS601620S, CWS601980S, CWS602302S, CWS602482S, CWS602880S, CWS602742S, CWS602559S, CWS602607S, CWS602433S, CWS602957S, CWS601056S, CWS601348S, CWS601807S, CWS602219S, CWS602422S, CWS602474S, CWS601519S, CWS601425S, CWS601296S, CWS602918S, CWS600483S, CWS600490S, CWS600494S, CWS600607S, CWS600960S, CWS601001S, CWS601199S, CWS601460S, CWS601594S, CWS601704S, CWS601713S, CWS601790S, CWS600422S, CWS600502S, CWS600125S, CWS600132S, CWS600342S, CWS600571S, CWS601791S, CWS600172S, CWS600318S, CWS600423S, CWS600453S, CWS600464S, CWS600686S, CWS601122S, CWS601155S, CWS601445S, CWS601981S, CWS601465S, CWS601628S, CWS600445S, CWS602676S, CWS600945S, CWS600142S, CWS600147S, CWS600178S, CWS600551S, CWS600557S, CWS600770S, CWS600996S, CWS601094S, CWS601323S, CWS601966S, CWS602181S, CWS602556S, CWS602618S, CWS602879S, CWS601541S, CWS601542S, CWS601203S, CWS601374S, CWS602139S, CWS600458S, CWS600102S, CWS600781S, CWS600759S, CWS600764S, CWS600765S, CWS600805S, CWS600806S, CWS600807S, CWS601024S, CWS601111S, CWS601201S, CWS601718S, CWS601979S, CWS602753S, CWS600731S, CWS601304S, CWS601780S, CWS602108S, CWS602214S, CWS601240S, CWS602411S, CWS602889S, CWS600108S, CWS601150S, CWS602620S, CWS601627S, CWS600523S, CWS600244S, CWS600631S, CWS600234S, CWS600315S, CWS600412S, CWS600432S, 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-1719-2023 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.