CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1770-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; 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 DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1770-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1770-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1770-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1770-2023
      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 00643169720749, Lot Serial Numbers: RPL202320H, RPL202797H, RPL202825H, RPL203304H, RPL203279H, RPL203319H, RPL203730H, RPL203754H, RPL204075H, RPL202479H, RPL202565H, RPL202842H, RPL203342H, RPL203518H, RPL203521H, RPL203522H, RPL203534H, RPL203543H, RPL203556H, RPL203602H, RPL203718H, RPL203723H, RPL203785H, RPL203210H, RPL202222H, RPL202318H, RPL202555H, RPL202697H, RPL202831H, RPL203172H, RPL202156H, RPL202223H, RPL202514H, RPL203290H, RPL203308H, RPL203446H, RPL202803H, RPL202347H, RPL202465H, RPL202684H, RPL202688H, RPL202707H, RPL202934H, RPL202972H, RPL203031H, RPL203078H, RPL203345H, RPL203399H, RPL203581H, RPL203623H, RPL203688H, RPL202382H, RPL202497H, RPL202590H, RPL203217H, RPL203225H, RPL203363H, RPL203369H, RPL203428H, RPL203479H, RPL203480H, RPL203484H, RPL203487H, RPL203488H, RPL203500H, RPL203513H, RPL203569H, RPL203794H, RPL202376H, RPL202499H, RPL202905H, RPL202940H, RPL203030H, RPL203784H, RPL203795H, RPL203957H, RPL202146H, RPL202538H, RPL202681H, RPL202892H, RPL202973H, RPL203164H, RPL202397H, RPL203253H, RPL203407H, RPL202200H, RPL202294H, RPL202834H, RPL202859H, RPL203075H, RPL203077H, RPL203104H, RPL203388H, RPL203560H, RPL203567H, RPL203574H, RPL203620H, RPL203670H, RPL202172H, RPL202308H, RPL202322H, RPL202336H, RPL202356H, RPL202440H, RPL202470H, RPL202571H, RPL202608H, RPL202765H, RPL202922H, RPL203011H, RPL203067H, RPL203227H, RPL203263H, RPL203265H, RPL203288H, RPL203376H, RPL203631H, RPL203635H, RPL203641H, RPL203642H, RPL203741H, RPL202613H, RPL202615H, RPL202713H, RPL202781H, RPL202978H, RPL203392H, RPL203503H, RPL203606H, RPL203661H, RPL203664H, RPL203748H, RPL203830H, RPL203930H, RPL203935H, RPL203978H, RPL204015H, RPL204048H, RPL204054H, RPL202464H, RPL202574H, RPL202140H, RPL202191H, RPL202689H, RPL202783H, RPL202853H, RPL202902H, RPL202942H, RPL202993H, RPL203070H, RPL203107H, RPL203127H, RPL203251H, RPL203586H, RPL203662H, RPL203885H, RPL202137H, RPL202196H, RPL202208H, RPL202209H, RPL202218H, RPL202220H, RPL202221H, RPL…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1770-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1770-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; 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 00643169720749, Lot Serial Numbers: RPL202320H, RPL202797H, RPL202825H, RPL203304H, RPL203279H, RPL203319H, RPL203730H, RPL203754H, RPL204075H, RPL202479H, RPL202565H, RPL202842H, RPL203342H, RPL203518H, RPL203521H, RPL203522H, RPL203534H, RPL203543H, RPL203556H, RPL203602H, RPL203718H, RPL203723H, RPL203785H, RPL203210H, RPL202222H, RPL202318H, RPL202555H, RPL202697H, RPL202831H, RPL203172H, RPL202156H, RPL202223H, RPL202514H, RPL203290H, RPL203308H, RPL203446H, RPL202803H, RPL202347H, RPL202465H, RPL202684H, RPL202688H, RPL202707H, RPL202934H, RPL202972H, RPL203031H, RPL203078H, RPL203345H, RPL203399H, RPL203581H, RPL203623H, RPL203688H, RPL202382H, RPL202497H, RPL202590H, RPL203217H, RPL203225H, RPL203363H, RPL203369H, RPL203428H, RPL203479H, RPL203480H, RPL203484H, RPL203487H, RPL203488H, RPL203500H, RPL203513H, RPL203569H, RPL203794H, RPL202376H, RPL202499H, RPL202905H, RPL202940H, RPL203030H, RPL203784H, RPL203795H, RPL203957H, RPL202146H, RPL202538H, RPL202681H, RPL202892H, RPL202973H, RPL203164H, RPL202397H, RPL203253H, RPL203407H, RPL202200H, RPL202294H, RPL202834H, RPL202859H, RPL203075H, RPL203077H, RPL203104H, RPL203388H, RPL203560H, RPL203567H, RPL203574H, RPL203620H, RPL203670H, RPL202172H, RPL202308H, RPL202322H, RPL202336H, RPL202356H, RPL202440H, RPL202470H, RPL202571H, RPL202608H, RPL202765H, RPL…
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-1770-2023 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.