CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1773-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; 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 DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1773-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1773-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1773-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1773-2023
      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 00643169720688, Lot Serial numbers: RPF622750S, RPF618290S, RPF616459S, RPF619209S, RPF620414S, RPF613519S, RPF617908S, RPF607263S, RPF605123S, RPF606355S, RPF607965S, RPF607966S, RPF607968S, RPF607969S, RPF610837S, RPF612639S, RPF613175S, RPF613176S, RPF614678S, RPF616130S, RPF616164S, RPF616174S, RPF616577S, RPF616578S, RPF617220S, RPF617584S, RPF617585S, RPF617586S, RPF619084S, RPF619475S, RPF619476S, RPF619729S, RPF609798S, RPF609803S, RPF609809S, RPF610924S, RPF610929S, RPF610935S, RPF610938S, RPF610947S, RPF614776S, RPF614782S, RPF618353S, RPF618354S, RPF618355S, RPF618356S, RPF618357S, RPF618358S, RPF618361S, RPF618362S, RPF608224S, RPF608225S, RPF611060S, RPF614821S, RPF616957S, RPF617031S, RPF618423S, RPF618476S, RPF619798S, RPF620332S, RPF621332S, RPF622094S, RPF620132S, RPF621989S, RPF615594S, RPF615595S, RPF620714S, RPF623023S, RPF612794S, RPF612795S, RPF612796S, RPF612799S, RPF612800S, RPF612801S, RPF612802S, RPF612829S, RPF612831S, RPF612833S, RPF613375S, RPF613376S, RPF613377S, RPF613378S, RPF613422S, RPF613858S, RPF613859S, RPF613860S, RPF613861S, RPF613862S, RPF613864S, RPF613865S, RPF613866S, RPF613867S, RPF613868S, RPF613869S, RPF613870S, RPF613874S, RPF613876S, RPF613881S, RPF613885S, RPF613887S, RPF614969S, RPF615082S, RPF615086S, RPF615260S, RPF615261S, RPF615268S, RPF615269S, RPF615273S, RPF615274S, RPF615275S, RPF615661S, RPF615676S, RPF615705S, RPF615710S, RPF615720S, RPF615724S, RPF615732S, RPF616201S, RPF616631S, RPF616709S, RPF617985S, RPF617986S, RPF617991S, RPF617995S, RPF617996S, RPF618455S, RPF618456S, RPF618457S, RPF618458S, RPF618459S, RPF618460S, RPF618462S, RPF618961S, RPF619265S, RPF619266S, RPF619276S, RPF619277S, RPF619280S, RPF619282S, RPF619283S, RPF619285S, RPF619514S, RPF619515S, RPF619520S, RPF619522S, RPF619571S, RPF620679S, RPF620683S, RPF620685S, RPF620686S, RPF620980S, RPF621053S, RPF621063S, RPF621070S, RPF621075S, RPF621089S, RPF621092S, RPF621096S, RPF621100S, RPF621103S, RPF621113S, RPF621220S, RPF621455S, RPF…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1773-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1773-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; 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 00643169720688, Lot Serial numbers: RPF622750S, RPF618290S, RPF616459S, RPF619209S, RPF620414S, RPF613519S, RPF617908S, RPF607263S, RPF605123S, RPF606355S, RPF607965S, RPF607966S, RPF607968S, RPF607969S, RPF610837S, RPF612639S, RPF613175S, RPF613176S, RPF614678S, RPF616130S, RPF616164S, RPF616174S, RPF616577S, RPF616578S, RPF617220S, RPF617584S, RPF617585S, RPF617586S, RPF619084S, RPF619475S, RPF619476S, RPF619729S, RPF609798S, RPF609803S, RPF609809S, RPF610924S, RPF610929S, RPF610935S, RPF610938S, RPF610947S, RPF614776S, RPF614782S, RPF618353S, RPF618354S, RPF618355S, RPF618356S, RPF618357S, RPF618358S, RPF618361S, RPF618362S, RPF608224S, RPF608225S, RPF611060S, RPF614821S, RPF616957S, RPF617031S, RPF618423S, RPF618476S, RPF619798S, RPF620332S, RPF621332S, RPF622094S, RPF620132S, RPF621989S, RPF615594S, RPF615595S, RPF620714S, RPF623023S, RPF612794S, RPF612795S, RPF612796S, RPF612799S, RPF612800S, RPF612801S, RPF612802S, RPF612829S, RPF612831S, RPF612833S, RPF613375S, RPF613376S, RPF613377S, RPF613378S, RPF613422S, RPF613858S, RPF613859S, RPF613860S, RPF613861S, RPF613862S, RPF613864S, RPF613865S, RPF613866S, RPF613867S, RPF613868S, RPF613869S, RPF613870S, RPF613874S, RPF613876S, RPF613881S, RPF613885S, RPF613887S, RPF614969S, RPF615082S, RPF615086S, RPF615260S, RPF615261S, RPF615268S, RPF615269S, RPF615273S, 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-1773-2023 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.