CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1760-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; 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 DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1760-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1760-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1760-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1760-2023
      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 00643169720640, Lot Serial Numbers: RPB618471S, RPB621777S, RPB619798S, RPB622872S, RPB620883S, RPB621725S, RPB612828S, RPB605719S, RPB615701S, RPB605409S, RPB609214S, RPB619400S, RPB611888S, RPB603955S, RPB617094S, RPB610684S, RPB603737S, RPB603739S, RPB603852S, RPB603887S, RPB603889S, RPB603892S, RPB604013S, RPB604131S, RPB604133S, RPB604139S, RPB604469S, RPB604482S, RPB604483S, RPB604484S, RPB604496S, RPB604508S, RPB604545S, RPB604692S, RPB604694S, RPB604731S, RPB605760S, RPB605763S, RPB605930S, RPB605982S, RPB606024S, RPB606084S, RPB606117S, RPB606124S, RPB606125S, RPB606136S, RPB606189S, RPB606190S, RPB606192S, RPB606492S, RPB606657S, RPB606773S, RPB606838S, RPB607008S, RPB607012S, RPB607049S, RPB607332S, RPB607709S, RPB607752S, RPB607793S, RPB607820S, RPB607825S, RPB607893S, RPB607897S, RPB607920S, RPB608192S, RPB608216S, RPB608222S, RPB608237S, RPB608293S, RPB608313S, RPB608351S, RPB608378S, RPB608498S, RPB608607S, RPB608621S, RPB608652S, RPB608696S, RPB608839S, RPB608867S, RPB609639S, RPB609652S, RPB609969S, RPB610019S, RPB610077S, RPB610186S, RPB610230S, RPB610431S, RPB610434S, RPB610437S, RPB610506S, RPB610813S, RPB610882S, RPB610955S, RPB611316S, RPB611327S, RPB611370S, RPB611482S, RPB611609S, RPB611651S, RPB611822S, RPB612129S, RPB612132S, RPB612533S, RPB612628S, RPB612917S, RPB612955S, RPB612965S, RPB613003S, RPB613214S, RPB613216S, RPB613537S, RPB613551S, RPB613616S, RPB613908S, RPB613910S, RPB613976S, RPB614145S, RPB614187S, RPB614232S, RPB614237S, RPB614239S, RPB614283S, RPB614346S, RPB614360S, RPB614447S, RPB615047S, RPB615050S, RPB615066S, RPB615285S, RPB615287S, RPB615306S, RPB615485S, RPB615486S, RPB615736S, RPB615763S, RPB616073S, RPB616074S, RPB616075S, RPB616079S, RPB616277S, RPB616295S, RPB616305S, RPB616362S, RPB616701S, RPB616702S, RPB616936S, RPB617009S, RPB617010S, RPB617045S, RPB617185S, RPB617239S, RPB617552S, RPB617556S, RPB617571S, RPB617578S, RPB617682S, RPB617777S, RPB617779S, RPB617823S, RPB618047S, RPB618077S, RPB618081S, RPB…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1760-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1760-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; 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 00643169720640, Lot Serial Numbers: RPB618471S, RPB621777S, RPB619798S, RPB622872S, RPB620883S, RPB621725S, RPB612828S, RPB605719S, RPB615701S, RPB605409S, RPB609214S, RPB619400S, RPB611888S, RPB603955S, RPB617094S, RPB610684S, RPB603737S, RPB603739S, RPB603852S, RPB603887S, RPB603889S, RPB603892S, RPB604013S, RPB604131S, RPB604133S, RPB604139S, RPB604469S, RPB604482S, RPB604483S, RPB604484S, RPB604496S, RPB604508S, RPB604545S, RPB604692S, RPB604694S, RPB604731S, RPB605760S, RPB605763S, RPB605930S, RPB605982S, RPB606024S, RPB606084S, RPB606117S, RPB606124S, RPB606125S, RPB606136S, RPB606189S, RPB606190S, RPB606192S, RPB606492S, RPB606657S, RPB606773S, RPB606838S, RPB607008S, RPB607012S, RPB607049S, RPB607332S, RPB607709S, RPB607752S, RPB607793S, RPB607820S, RPB607825S, RPB607893S, RPB607897S, RPB607920S, RPB608192S, RPB608216S, RPB608222S, RPB608237S, RPB608293S, RPB608313S, RPB608351S, RPB608378S, RPB608498S, RPB608607S, RPB608621S, RPB608652S, RPB608696S, RPB608839S, RPB608867S, RPB609639S, RPB609652S, RPB609969S, RPB610019S, RPB610077S, RPB610186S, RPB610230S, RPB610431S, RPB610434S, RPB610437S, RPB610506S, RPB610813S, RPB610882S, RPB610955S, RPB611316S, RPB611327S, RPB611370S, RPB611482S, RPB611609S, RPB611651S, RPB611822S, RPB612129S, RPB612132S, RPB612533S, RPB612628S, RPB612917S, RPB612955S, RPB612965S, RP…
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-1760-2023 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.