CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1772-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; 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: CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1772-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1772-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1772-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1772-2023
      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 00643169720701, Lot Serial Numbers: RPH603922S, RPH608147S, RPH603531S, RPH607413S, RPH607373S, RPH604394S, RPH606758S, RPH603572S, RPH606941S, RPH603152S, RPH603203S, RPH603999S, RPH604021S, RPH606976S, RPH603841S, RPH604928S, RPH605779S, RPH605780S, RPH606559S, RPH606577S, RPH606694S, RPH606731S, RPH606795S, RPH607014S, RPH607015S, RPH607016S, RPH607157S, RPH607244S, RPH607443S, RPH607748S, RPH608114S, RPH607674S, RPH607675S, RPH607677S, RPH607681S, RPH607688S, RPH609399S, RPH607884S, RPH608003S, RPH608138S, RPH608464S, RPH608655S, RPH608676S, RPH608835S, RPH608853S, RPH608950S, RPH608952S, RPH608958S, RPH609021S, RPH609279S, RPH609280S, RPH609281S, RPH609282S, RPH607432S, RPH609308S, RPH607753S, RPH603849S, RPH603912S, RPH603913S, RPH604139S, RPH604140S, RPH604142S, RPH604266S, RPH604267S, RPH604268S, RPH604435S, RPH604692S, RPH604708S, RPH604785S, RPH605048S, RPH605058S, RPH605167S, RPH605790S, RPH605824S, RPH605882S, RPH606393S, RPH606447S, RPH606491S, RPH606568S, RPH607305S, RPH607306S, RPH607412S, RPH607414S, RPH607568S, RPH607801S, RPH607969S, RPH607970S, RPH608423S, RPH608424S, RPH608644S, RPH609447S, RPH609514S, RPH604243S, RPH602654S, RPH603493S, RPH603502S, RPH607247S, RPH607311S, RPH609270S, RPH603130S, RPH603730S, RPH603928S, RPH604193S, RPH604283S, RPH603527S, RPH602526S, RPH603472S, RPH603477S, RPH603490S, RPH604194S, RPH604360S, RPH607312S, RPH607757S, RPH602973S, RPH603497S, RPH604189S, RPH604285S, RPH604877S, RPH603478S, RPH603727S, RPH604282S, RPH603495S, RPH602524S, RPH603487S, RPH607146S, RPH607193S, RPH608131S, RPH608313S, RPH608415S, RPH609276S, RPH603733S, RPH603739S, RPH603931S, RPH603037S, RPH603732S, RPH609273S, RPH604835S, RPH604909S, RPH608314S, RPH609241S, RPH602522S, RPH603807S, RPH604196S, RPH604836S, RPH604869S, RPH602513S, RPH602830S, RPH603092S, RPH603530S, RPH606332S, RPH602533S, RPH602549S, RPH603930S, RPH604300S, RPH607279S, RPH608629S, RPH608734S, RPH603871S, RPH604654S, RPH606983S, RPH608661S, RPH607700S, RPH607783S, RPH…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1772-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1772-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; 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 00643169720701, Lot Serial Numbers: RPH603922S, RPH608147S, RPH603531S, RPH607413S, RPH607373S, RPH604394S, RPH606758S, RPH603572S, RPH606941S, RPH603152S, RPH603203S, RPH603999S, RPH604021S, RPH606976S, RPH603841S, RPH604928S, RPH605779S, RPH605780S, RPH606559S, RPH606577S, RPH606694S, RPH606731S, RPH606795S, RPH607014S, RPH607015S, RPH607016S, RPH607157S, RPH607244S, RPH607443S, RPH607748S, RPH608114S, RPH607674S, RPH607675S, RPH607677S, RPH607681S, RPH607688S, RPH609399S, RPH607884S, RPH608003S, RPH608138S, RPH608464S, RPH608655S, RPH608676S, RPH608835S, RPH608853S, RPH608950S, RPH608952S, RPH608958S, RPH609021S, RPH609279S, RPH609280S, RPH609281S, RPH609282S, RPH607432S, RPH609308S, RPH607753S, RPH603849S, RPH603912S, RPH603913S, RPH604139S, RPH604140S, RPH604142S, RPH604266S, RPH604267S, RPH604268S, RPH604435S, RPH604692S, RPH604708S, RPH604785S, RPH605048S, RPH605058S, RPH605167S, RPH605790S, RPH605824S, RPH605882S, RPH606393S, RPH606447S, RPH606491S, RPH606568S, RPH607305S, RPH607306S, RPH607412S, RPH607414S, RPH607568S, RPH607801S, RPH607969S, RPH607970S, RPH608423S, RPH608424S, RPH608644S, RPH609447S, RPH609514S, RPH604243S, RPH602654S, RPH603493S, RPH603502S, RPH607247S, RPH607311S, RPH609270S, RPH603130S, RPH603730S, RPH603928S, RPH604193S, RPH604283S, RPH603527S, RPH602526S, RPH603472S, RPH603477S, RPH6034…
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-1772-2023 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.