CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1784-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; 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 COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1784-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1784-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1784-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1784-2023
      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 00763000178178, Lot Serial numbers: RTK605097S, RTK600114S, RTK600141S, RTK600852S, RTK600858S, RTK601106S, RTK601201S, RTK602089S, RTK602953S, RTK603591S, RTK604031S, RTK600525S, RTK602527S, RTK606714S, RTK608837S, RTK608930S, RTK610777S, RTK600938S, RTK600939S, RTK600940S, RTK601391S, RTK601392S, RTK601393S, RTK601395S, RTK604983S, RTK604984S, RTK604033S, RTK606189S, RTK606293S, RTK606647S, RTK606683S, RTK606985S, RTK606988S, RTK607188S, RTK607189S, RTK607190S, RTK607191S, RTK607242S, RTK610835S, RTK603685S, RTK605333S, RTK601363S, RTK602275S, RTK602876S, RTK603055S, RTK600536S, RTK603273S, RTK603414S, RTK603912S, RTK604677S, RTK602444S, RTK602532S, RTK602533S, RTK602534S, RTK603360S, RTK603873S, RTK603874S, RTK603875S, RTK604155S, RTK604215S, RTK604626S, RTK607991S, RTK604065S, RTK604500S, RTK604161S, RTK610478S, RTK601877S, RTK606247S, RTK600611S, RTK609287S, RTK609288S, RTK609289S, RTK609290S, RTK609291S, RTK609293S, RTK609294S, RTK609295S, RTK609296S, RTK600247S, RTK600372S, RTK600622S, RTK601085S, RTK601214S, RTK602561S, RTK603534S, RTK603779S, RTK603793S, RTK603825S, RTK604693S, RTK604866S, RTK606038S, RTK609026S, RTK611004S, RTK617383S, RTK617202S, RTK605241S, RTK606999S, RTK609748S, RTK605348S, RTK605349S, RTK605351S, RTK605352S, RTK601439S, RTK601440S, RTK602471S, RTK602473S, RTK605980S, RTK605981S, RTK606707S, RTK606709S, RTK607336S, RTK617303S, RTK610172S, RTK601229S, RTK602257S, RTK602372S, RTK602380S, RTK603712S, RTK603886S, RTK604175S, RTK604227S, RTK604456S, RTK604474S, RTK604495S, RTK604749S, RTK604800S, RTK605014S, RTK605112S, RTK605792S, RTK605919S, RTK606373S, RTK606394S, RTK606397S, RTK606464S, RTK606471S, RTK606813S, RTK607342S, RTK608189S, RTK608458S, RTK602142S, RTK605013S, RTK606202S, RTK607771S, RTK607793S, RTK600208S, RTK603060S, RTK604059S, RTK606577S, RTK609486S, RTK607691S, RTK608310S, RTK615038S, RTK604862S, RTK604919S, RTK601156S, RTK601210S, RTK601260S, RTK601383S, RTK601871S, RTK602614S, RTK601083S, RTK602155S, RTK603161S, RTK…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1784-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1784-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; 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 00763000178178, Lot Serial numbers: RTK605097S, RTK600114S, RTK600141S, RTK600852S, RTK600858S, RTK601106S, RTK601201S, RTK602089S, RTK602953S, RTK603591S, RTK604031S, RTK600525S, RTK602527S, RTK606714S, RTK608837S, RTK608930S, RTK610777S, RTK600938S, RTK600939S, RTK600940S, RTK601391S, RTK601392S, RTK601393S, RTK601395S, RTK604983S, RTK604984S, RTK604033S, RTK606189S, RTK606293S, RTK606647S, RTK606683S, RTK606985S, RTK606988S, RTK607188S, RTK607189S, RTK607190S, RTK607191S, RTK607242S, RTK610835S, RTK603685S, RTK605333S, RTK601363S, RTK602275S, RTK602876S, RTK603055S, RTK600536S, RTK603273S, RTK603414S, RTK603912S, RTK604677S, RTK602444S, RTK602532S, RTK602533S, RTK602534S, RTK603360S, RTK603873S, RTK603874S, RTK603875S, RTK604155S, RTK604215S, RTK604626S, RTK607991S, RTK604065S, RTK604500S, RTK604161S, RTK610478S, RTK601877S, RTK606247S, RTK600611S, RTK609287S, RTK609288S, RTK609289S, RTK609290S, RTK609291S, RTK609293S, RTK609294S, RTK609295S, RTK609296S, RTK600247S, RTK600372S, RTK600622S, RTK601085S, RTK601214S, RTK602561S, RTK603534S, RTK603779S, RTK603793S, RTK603825S, RTK604693S, RTK604866S, RTK606038S, RTK609026S, RTK611004S, RTK617383S, RTK617202S, RTK605241S, RTK606999S, RTK609748S, RTK605348S, RTK605349S, RTK605351S, RTK605352S, RTK601439S, RTK601440S, RTK602471S, RTK602473S, RTK605980S, RTK605981S, RTK606…
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-1784-2023 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.