CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1764-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; 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 DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1764-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1764-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1764-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1764-2023
      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 00643169720671, Lot Serial Numbers: RPE221706H, RPE221707H, RPE221708H, RPE221712H, RPE221714H, RPE221715H, RPE222453H, RPE222479H, RPE222484H, RPE222493H, RPE223082H, RPE223083H, RPE223085H, RPE223086H, RPE223087H, RPE224112H, RPE224115H, RPE224116H, RPE224117H, RPE221282H, RPE222157H, RPE222778H, RPE222899H, RPE223002H, RPE223681H, RPE222052H, RPE224096H, RPE224699H, RPE225223H, RPE225228H, RPE225260H, RPE226241H, RPE226280H, RPE226296H, RPE226578H, RPE226614H, RPE226861H, RPE227698H, RPE227755H, RPE223791H, RPE226062H, RPE221213H, RPE221541H, RPE221727H, RPE221823H, RPE222060H, RPE222451H, RPE222481H, RPE222548H, RPE222618H, RPE222760H, RPE222970H, RPE222978H, RPE223026H, RPE224464H, RPE224543H, RPE224745H, RPE225324H, RPE225723H, RPE225724H, RPE225729H, RPE225737H, RPE220952H, RPE220957H, RPE220960H, RPE221018H, RPE221039H, RPE221251H, RPE221335H, RPE221336H, RPE222358H, RPE223216H, RPE223219H, RPE224021H, RPE224024H, RPE224026H, RPE224029H, RPE224031H, RPE224032H, RPE224827H, RPE224828H, RPE224829H, RPE224830H, RPE224832H, RPE224833H, RPE224834H, RPE224835H, RPE224836H, RPE224837H, RPE224838H, RPE224840H, RPE224841H, RPE224844H, RPE225172H, RPE221479H, RPE221865H, RPE221947H, RPE222309H, RPE222434H, RPE221087H, RPE221344H, RPE221345H, RPE221346H, RPE221889H, RPE222001H, RPE222150H, RPE222161H, RPE222223H, RPE222587H, RPE222591H, RPE222600H, RPE223003H, RPE223014H, RPE223046H, RPE223190H, RPE223192H, RPE223193H, RPE223197H, RPE223199H, RPE223203H, RPE223533H, RPE223901H, RPE224166H, RPE224327H, RPE224426H, RPE224487H, RPE224631H, RPE224654H, RPE224685H, RPE224689H, RPE224852H, RPE224853H, RPE224854H, RPE224855H, RPE224857H, RPE224858H, RPE224859H, RPE225740H, RPE225743H, RPE225744H, RPE225745H, RPE225747H, RPE225971H, RPE225973H, RPE226102H, RPE226145H, RPE226168H, RPE226246H, RPE226486H, RPE226487H, RPE226531H, RPE226535H, RPE226537H, RPE226539H, RPE226918H, RPE226919H, RPE226979H, RPE227184H, RPE224131H, RPE227055H, RPE227907H, RPE223074H, RPE223117H, RPE…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1764-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1764-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; 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 00643169720671, Lot Serial Numbers: RPE221706H, RPE221707H, RPE221708H, RPE221712H, RPE221714H, RPE221715H, RPE222453H, RPE222479H, RPE222484H, RPE222493H, RPE223082H, RPE223083H, RPE223085H, RPE223086H, RPE223087H, RPE224112H, RPE224115H, RPE224116H, RPE224117H, RPE221282H, RPE222157H, RPE222778H, RPE222899H, RPE223002H, RPE223681H, RPE222052H, RPE224096H, RPE224699H, RPE225223H, RPE225228H, RPE225260H, RPE226241H, RPE226280H, RPE226296H, RPE226578H, RPE226614H, RPE226861H, RPE227698H, RPE227755H, RPE223791H, RPE226062H, RPE221213H, RPE221541H, RPE221727H, RPE221823H, RPE222060H, RPE222451H, RPE222481H, RPE222548H, RPE222618H, RPE222760H, RPE222970H, RPE222978H, RPE223026H, RPE224464H, RPE224543H, RPE224745H, RPE225324H, RPE225723H, RPE225724H, RPE225729H, RPE225737H, RPE220952H, RPE220957H, RPE220960H, RPE221018H, RPE221039H, RPE221251H, RPE221335H, RPE221336H, RPE222358H, RPE223216H, RPE223219H, RPE224021H, RPE224024H, RPE224026H, RPE224029H, RPE224031H, RPE224032H, RPE224827H, RPE224828H, RPE224829H, RPE224830H, RPE224832H, RPE224833H, RPE224834H, RPE224835H, RPE224836H, RPE224837H, RPE224838H, RPE224840H, RPE224841H, RPE224844H, RPE225172H, RPE221479H, RPE221865H, RPE221947H, RPE222309H, RPE222434H, RPE221087H, RPE221344H, RPE221345H, RPE221346H, RPE221889H, RPE222001H, RPE222150H, RPE222161H, RPE222223H, RPE…
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-1764-2023 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.