CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1767-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; 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 DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1767-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1767-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1767-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1767-2023
      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 00643169837638, Lot Serial Numbers: RPP602125S, RPP602593S, RPP603699S, RPP602902S, RPP602417S, RPP601873S, RPP602956S, RPP601533S, RPP603620S, RPP600808S, RPP603725S, RPP602431S, RPP602451S, RPP602452S, RPP602460S, RPP602737S, RPP602741S, RPP602778S, RPP602780S, RPP603298S, RPP603299S, RPP603300S, RPP603303S, RPP603679S, RPP603685S, RPP603686S, RPP603690S, RPP603812S, RPP603814S, RPP603815S, RPP603819S, RPP603821S, RPP603822S, RPP603825S, RPP603832S, RPP603833S, RPP603840S, RPP603843S, RPP603844S, RPP603847S, RPP603848S, RPP603849S, RPP603852S, RPP603855S, RPP603859S, RPP603860S, RPP603861S, RPP603862S, RPP603863S, RPP603868S, RPP603870S, RPP603871S, RPP602254S, RPP603326S, RPP601331S, RPP601392S, RPP602961S, RPP601050S, RPP602800S, RPP603221S, RPP602233S, RPP603560S, RPP603768S, RPP603806S, RPP600598S, RPP602145S, RPP602648S, RPP602799S, RPP603486S, RPP603323S, RPP600640S, RPP602076S, RPP602927S, RPP602720S, RPP602731S, RPP602825S, RPP603224S, RPP603469S, RPP603540S, RPP603121S, RPP601248S, RPP603177S, RPP603172S, RPP603771S, RPP602869S, RPP601435S, RPP601415S, RPP600928S, RPP601427S, RPP602144S, RPP603032S, RPP603520S, RPP602501S, RPP603038S, RPP601593S, RPP602078S, RPP602304S, RPP602511S, RPP602666S, RPP603530S, RPP603735S, RPP603818S, RPP601857S, RPP601924S, RPP602614S, RPP602678S, RPP602682S, RPP601024S, RPP603775S, RPP600608S, RPP602566S, RPP603774S, RPP602077S, RPP603233S, RPP603275S, RPP603548S, RPP603666S, RPP601938S, RPP601669S, RPP601446S, RPP602806S, RPP602014S, RPP602046S, RPP602127S, RPP602288S, RPP602299S, RPP602442S, RPP602534S, RPP602537S, RPP602588S, RPP602840S, RPP603012S, RPP603063S, RPP603478S, RPP603522S, RPP603633S, RPP600759S, RPP600636S, RPP600852S, RPP601668S, RPP601997S, RPP602083S, RPP602789S, RPP602807S, RPP602433S, RPP602622S, RPP602919S, RPP602243S, RPP603311S, RPP602689S, RPP602818S, RPP602951S, RPP602967S, RPP602324S, RPP603049S, RPP602019S, RPP601793S, RPP602824S, RPP602850S, RPP603226S, RPP603375S, RPP603381S, RPP602337S, RPP…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1767-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1767-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; 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 00643169837638, Lot Serial Numbers: RPP602125S, RPP602593S, RPP603699S, RPP602902S, RPP602417S, RPP601873S, RPP602956S, RPP601533S, RPP603620S, RPP600808S, RPP603725S, RPP602431S, RPP602451S, RPP602452S, RPP602460S, RPP602737S, RPP602741S, RPP602778S, RPP602780S, RPP603298S, RPP603299S, RPP603300S, RPP603303S, RPP603679S, RPP603685S, RPP603686S, RPP603690S, RPP603812S, RPP603814S, RPP603815S, RPP603819S, RPP603821S, RPP603822S, RPP603825S, RPP603832S, RPP603833S, RPP603840S, RPP603843S, RPP603844S, RPP603847S, RPP603848S, RPP603849S, RPP603852S, RPP603855S, RPP603859S, RPP603860S, RPP603861S, RPP603862S, RPP603863S, RPP603868S, RPP603870S, RPP603871S, RPP602254S, RPP603326S, RPP601331S, RPP601392S, RPP602961S, RPP601050S, RPP602800S, RPP603221S, RPP602233S, RPP603560S, RPP603768S, RPP603806S, RPP600598S, RPP602145S, RPP602648S, RPP602799S, RPP603486S, RPP603323S, RPP600640S, RPP602076S, RPP602927S, RPP602720S, RPP602731S, RPP602825S, RPP603224S, RPP603469S, RPP603540S, RPP603121S, RPP601248S, RPP603177S, RPP603172S, RPP603771S, RPP602869S, RPP601435S, RPP601415S, RPP600928S, RPP601427S, RPP602144S, RPP603032S, RPP603520S, RPP602501S, RPP603038S, RPP601593S, RPP602078S, RPP602304S, RPP602511S, RPP602666S, RPP603530S, RPP603735S, RPP603818S, RPP601857S, RPP601924S, RPP602614S, RPP602678S, RPP602682S, RPP601024S, RP…
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-1767-2023 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.