CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1753-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; 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 DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1753-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1753-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1753-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1753-2023
      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 00643169837676, Lot Serial Numbers: RPT208454H, RPT211000H, RPT208258H, RPT211071H, RPT211077H, RPT210886H, RPT209224H, RPT211338H, RPT211343H, RPT211344H, RPT211347H, RPT208864H, RPT210392H, RPT204063H, RPT207540H, RPT210779H, RPT211477H, RPT210662H, RPT203810H, RPT204233H, RPT210695H, RPT204352H, RPT204713H, RPT205727H, RPT208222H, RPT208507H, RPT210829H, RPT211217H, RPT206139H, RPT207062H, RPT210688H, RPT210917H, RPT203993H, RPT205235H, RPT205768H, RPT206518H, RPT206833H, RPT209343H, RPT209843H, RPT205560H, RPT206519H, RPT210915H, RPT210978H, RPT207320H, RPT204196H, RPT205788H, RPT207588H, RPT209206H, RPT209796H, RPT210253H, RPT210444H, RPT210700H, RPT211542H, RPT211685H, RPT205575H, RPT205841H, RPT207926H, RPT204420H, RPT205180H, RPT204120H, RPT204133H, RPT209974H, RPT205340H, RPT209909H, RPT210452H, RPT211124H, RPT203859H, RPT205468H, RPT208257H, RPT208621H, RPT209674H, RPT211043H, RPT210842H, RPT211476H, RPT207094H, RPT208370H, RPT206004H, RPT206049H, RPT210092H, RPT210217H, RPT211406H, RPT204980H, RPT205294H, RPT208424H, RPT208705H, RPT209144H, RPT209238H, RPT209858H, RPT210083H, RPT210593H, RPT210747H, RPT210979H, RPT211230H, RPT211701H, RPT209577H, RPT209848H, RPT211158H, RPT205289H, RPT206148H, RPT209521H, RPT204605H, RPT206936H, RPT207571H, RPT209334H, RPT209373H, RPT204461H, RPT207429H, RPT209096H, RPT210964H, RPT211140H, RPT205903H, RPT208605H, RPT211566H, RPT206634H, RPT203640H, RPT203792H, RPT203793H, RPT203795H, RPT204568H, RPT204574H, RPT204577H, RPT204582H, RPT204584H, RPT204607H, RPT205619H, RPT205620H, RPT205622H, RPT205624H, RPT206785H, RPT207549H, RPT207550H, RPT207556H, RPT207561H, RPT207562H, RPT207566H, RPT207568H, RPT208590H, RPT208591H, RPT208597H, RPT208599H, RPT208601H, RPT209722H, RPT210663H, RPT210668H, RPT210670H, RPT208269H, RPT206355H, RPT208891H, RPT205697H, RPT205434H, RPT210488H, RPT204439H, RPT207232H, RPT208034H, RPT209462H, RPT203726H, RPT206932H, RPT207021H, RPT210596H, RPT211478H, RPT210913H, RPT203791H, RPT205433H, RPT…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1753-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1753-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; 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 00643169837676, Lot Serial Numbers: RPT208454H, RPT211000H, RPT208258H, RPT211071H, RPT211077H, RPT210886H, RPT209224H, RPT211338H, RPT211343H, RPT211344H, RPT211347H, RPT208864H, RPT210392H, RPT204063H, RPT207540H, RPT210779H, RPT211477H, RPT210662H, RPT203810H, RPT204233H, RPT210695H, RPT204352H, RPT204713H, RPT205727H, RPT208222H, RPT208507H, RPT210829H, RPT211217H, RPT206139H, RPT207062H, RPT210688H, RPT210917H, RPT203993H, RPT205235H, RPT205768H, RPT206518H, RPT206833H, RPT209343H, RPT209843H, RPT205560H, RPT206519H, RPT210915H, RPT210978H, RPT207320H, RPT204196H, RPT205788H, RPT207588H, RPT209206H, RPT209796H, RPT210253H, RPT210444H, RPT210700H, RPT211542H, RPT211685H, RPT205575H, RPT205841H, RPT207926H, RPT204420H, RPT205180H, RPT204120H, RPT204133H, RPT209974H, RPT205340H, RPT209909H, RPT210452H, RPT211124H, RPT203859H, RPT205468H, RPT208257H, RPT208621H, RPT209674H, RPT211043H, RPT210842H, RPT211476H, RPT207094H, RPT208370H, RPT206004H, RPT206049H, RPT210092H, RPT210217H, RPT211406H, RPT204980H, RPT205294H, RPT208424H, RPT208705H, RPT209144H, RPT209238H, RPT209858H, RPT210083H, RPT210593H, RPT210747H, RPT210979H, RPT211230H, RPT211701H, RPT209577H, RPT209848H, RPT211158H, RPT205289H, RPT206148H, RPT209521H, RPT204605H, RPT206936H, RPT207571H, RPT209334H, RPT209373H, RPT204461H, RPT207429H, RPT209096H, RPT21096…
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-1753-2023 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.