CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1755-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; 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 DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1755-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1755-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1755-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1755-2023
      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 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS206225H, RPS208216H, RPS206084H, RPS203804H, RPS208198H, RPS208245H, RPS205937H, RPS205565H, RPS206114H, RPS206723H, RPS206730H, RPS206733H, RPS206734H, RPS206754H, RPS207303H, RPS207318H, RPS207338H, RPS207399H, RPS207703H, RPS207711H, RPS207722H, RPS208049H, RPS208505H, RPS208646H, RPS208679H, RPS205303H, RPS205918H, RPS203315H, RPS204385H, RPS205650H, RPS202760H, RPS203013H, RPS203034H, RPS203256H, RPS203610H, RPS205372H, RPS206383H, RPS206771H, RPS207603H, RPS207933H, RPS208110H, RPS208492H, RPS204009H, RPS202981H, RPS207563H, RPS208546H, RPS202245H, RPS203960H, RPS204342H, RPS204357H, RPS205958H, RPS207822H, RPS207840H, RPS207922H, RPS207923H, RPS207984H, RPS208255H, RPS208529H, RPS208575H, RPS208590H, RPS208615H, RPS203563H, RPS206128H, RPS206413H, RPS206762H, RPS207904H, RPS208608H, RPS202171H, RPS202841H, RPS202860H, RPS203565H, RPS204198H, RPS202792H, RPS202793H, RPS206515H, RPS202224H, RPS203192H, RPS203545H, RPS203910H, RPS204035H, RPS204166H, RPS204197H, RPS204394H, RPS204492H, RPS205560H, RPS206777H, RPS207146H, RPS207520H, RPS208166H, RPS204464H, RPS204776H, RPS207117H, RPS204003H, RPS205323H, RPS206063H, RPS208464H, RPS206252H, RPS202211H, RPS202602H, RPS202612H, RPS205006H, RPS205638H, RPS205639H, RPS205710H, RPS205998H, RPS207105H, RPS207368H, RPS207409H, RPS202030H, RPS202067H, RPS202507H, RPS206211H, RPS206605H, RPS207137H, RPS208591H, RPS202053H, RPS202511H, RPS202116H, RPS202210H, RPS202273H, RPS202274H, RPS202276H, RPS202307H, RPS202349H, RPS202427H, RPS202447H, RPS202498H, RPS202527H, RPS202601H, RPS202603H, RPS202605H, RPS203195H, RPS203197H, RPS203431H, RPS203432H, RPS203433H, RPS203435H, RPS203436H, RPS203438H, RPS203439H, RPS203440H, RPS203441H, RPS203442H, RPS203444H, RPS204202H, RPS204209H, RPS204210H, RPS204212H, RPS204215H, RPS204217H, RPS204223H, RPS204926H, RPS204978H, RPS204980H, RPS204983H, RPS204986H, RPS204987H, RPS…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1755-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1755-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; 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 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS206225H, RPS208216H, RPS206084H, RPS203804H, RPS208198H, RPS208245H, RPS205937H, RPS205565H, RPS206114H, RPS206723H, RPS206730H, RPS206733H, RPS206734H, RPS206754H, RPS207303H, RPS207318H, RPS207338H, RPS207399H, RPS207703H, RPS207711H, RPS207722H, RPS208049H, RPS208505H, RPS208646H, RPS208679H, RPS205303H, RPS205918H, RPS203315H, RPS204385H, RPS205650H, RPS202760H, RPS203013H, RPS203034H, RPS203256H, RPS203610H, RPS205372H, RPS206383H, RPS206771H, RPS207603H, RPS207933H, RPS208110H, RPS208492H, RPS204009H, RPS202981H, RPS207563H, RPS208546H, RPS202245H, RPS203960H, RPS204342H, RPS204357H, RPS205958H, RPS207822H, RPS207840H, RPS207922H, RPS207923H, RPS207984H, RPS208255H, RPS208529H, RPS208575H, RPS208590H, RPS208615H, RPS203563H, RPS206128H, RPS206413H, RPS206762H, RPS207904H, RPS208608H, RPS202171H, RPS202841H, RPS202860H, RPS203565H, RPS204198H, RPS202792H, RPS202793H, RPS206515H, RPS202224H, RPS203192H, RPS203545H, RPS203910H, RPS204035H, RPS204166H, RPS204197H, RPS204394H, RPS204492H, RPS205560H, RPS206777H, RPS207146H, RPS207520H, RPS208166H, RPS204464H, RPS204776H, RPS207117H, RPS204003H, RPS205323H, RPS206063H, RPS208464H, RPS206252H, RPS202211H, RPS202602H, RPS202612H, RPS205006H, RPS205638H, RPS…
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-1755-2023 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.