CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1756-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; 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 DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1756-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1756-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1756-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1756-2023
      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 CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Lot Serial Numbers: RPA210493H, RPA222265H, RPA231080H, RPA238029H, RPA220160H, RPA224981H, RPA226922H, RPA226926H, RPA226931H, RPA226935H, RPA226936H, RPA231700H, RPA231701H, RPA231707H, RPA231708H, RPA231711H, RPA235632H, RPA235645H, RPA235649H, RPA240455H, RPA240473H, RPA240476H, RPA240477H, RPA214967H, RPA219025H, RPA220582H, RPA224560H, RPA229904H, RPA230197H, RPA232865H, RPA239124H, RPA240812H, RPA240813H, RPA240814H, RPA240817H, RPA240821H, RPA240822H, RPA240825H, RPA240831H, RPA240834H, RPA240838H, RPA220840H, RPA225194H, RPA233160H, RPA242772H, RPA222022H, RPA222334H, RPA226679H, RPA228141H, RPA228927H, RPA229342H, RPA229425H, RPA240558H, RPA241482H, RPA242003H, RPA242887H, RPA240059H, RPA240830H, RPA242610H, RPA242611H, RPA242695H, RPA242800H, RPA243342H, RPA243356H, RPA243358H, RPA232874H, RPA240168H, RPA208767H, RPA208769H, RPA211496H, RPA212326H, RPA213403H, RPA213430H, RPA215858H, RPA215861H, RPA215864H, RPA222904H, RPA222906H, RPA226778H, RPA231563H, RPA231566H, RPA231568H, RPA232553H, RPA236837H, RPA236840H, RPA236842H, RPA241975H, RPA226862H, RPA241003H, RPA212993H, RPA214389H, RPA214965H, RPA215497H, RPA216355H, RPA217813H, RPA219094H, RPA219114H, RPA219572H, RPA220241H, RPA220423H, RPA221111H, RPA221472H, RPA221992H, RPA225446H, RPA225795H, RPA229499H, RPA229970H, RPA232311H, RPA232642H, RPA234946H, RPA235316H, RPA237387H, RPA242986H, RPA207873H, RPA209580H, RPA209689H, RPA210826H, RPA212257H, RPA214152H, RPA214329H, RPA215578H, RPA217457H, RPA218714H, RPA220281H, RPA221996H, RPA222612H, RPA224849H, RPA225079H, RPA225211H, RPA226958H, RPA229601H, RPA231741H, RPA232753H, RPA237566H, RPA238249H, RPA241120H, RPA210661H, RPA211961H, RPA207898H, RPA207918H, RPA207952H, RPA209965H, RPA210682H, RPA210792H, RPA214197H, RPA214422H, RPA216081H, RPA216767H, RPA216939H, RPA217052H, RPA217524H, RPA217831H, RPA217920H, RPA217947H, RPA219281H, RPA219405H, RPA219812H, RPA220220H, RPA221473H, RPA221920H, RPA222051H, RPA225…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1756-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1756-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; 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 CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Lot Serial Numbers: RPA210493H, RPA222265H, RPA231080H, RPA238029H, RPA220160H, RPA224981H, RPA226922H, RPA226926H, RPA226931H, RPA226935H, RPA226936H, RPA231700H, RPA231701H, RPA231707H, RPA231708H, RPA231711H, RPA235632H, RPA235645H, RPA235649H, RPA240455H, RPA240473H, RPA240476H, RPA240477H, RPA214967H, RPA219025H, RPA220582H, RPA224560H, RPA229904H, RPA230197H, RPA232865H, RPA239124H, RPA240812H, RPA240813H, RPA240814H, RPA240817H, RPA240821H, RPA240822H, RPA240825H, RPA240831H, RPA240834H, RPA240838H, RPA220840H, RPA225194H, RPA233160H, RPA242772H, RPA222022H, RPA222334H, RPA226679H, RPA228141H, RPA228927H, RPA229342H, RPA229425H, RPA240558H, RPA241482H, RPA242003H, RPA242887H, RPA240059H, RPA240830H, RPA242610H, RPA242611H, RPA242695H, RPA242800H, RPA243342H, RPA243356H, RPA243358H, RPA232874H, RPA240168H, RPA208767H, RPA208769H, RPA211496H, RPA212326H, RPA213403H, RPA213430H, RPA215858H, RPA215861H, RPA215864H, RPA222904H, RPA222906H, RPA226778H, RPA231563H, RPA231566H, RPA231568H, RPA232553H, RPA236837H, RPA236840H, RPA236842H, RPA241975H, RPA226862H, RPA241003H, RPA212993H, RPA214389H, RPA214965H, RPA215497H, RPA216355H, RPA217813H, RPA219094H, RPA219114H, RPA219572H, RPA220241H, RPA220423H, RPA221111H, RPA221472H, RPA221992H, RPA225446H, RPA225795H, RPA229499H, RPA229…
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-1756-2023 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.