CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1779-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; 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 XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1779-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1779-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1779-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1779-2023
      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 00763000178093, Lot Serial Numbers: RTC605498S, RTC605500S, RTC605501S, RTC605502S, RTC607884S, RTC607885S, RTC608196S, RTC608199S, RTC608200S, RTC610884S, RTC610885S, RTC610887S, RTC610889S, RTC610890S, RTC610892S, RTC626989S, RTC626991S, RTC626992S, RTC626996S, RTC604820S, RTC605664S, RTC606411S, RTC606605S, RTC613019S, RTC613629S, RTC614078S, RTC612708S, RTC614277S, RTC611123S, RTC611127S, RTC611128S, RTC613158S, RTC613159S, RTC613160S, RTC613162S, RTC613164S, RTC613165S, RTC613166S, RTC626776S, RTC626778S, RTC626780S, RTC612365S, RTC612540S, RTC612629S, RTC614220S, RTC600235S, RTC600300S, RTC600381S, RTC600573S, RTC602541S, RTC602726S, RTC605274S, RTC605795S, RTC607215S, RTC607469S, RTC608981S, RTC609490S, RTC610107S, RTC610867S, RTC613560S, RTC614081S, RTC600433S, RTC600555S, RTC600556S, RTC600576S, RTC600703S, RTC604519S, RTC605238S, RTC605983S, RTC606093S, RTC606096S, RTC607001S, RTC607069S, RTC607165S, RTC607228S, RTC607497S, RTC609933S, RTC609934S, RTC614263S, RTC616913S, RTC626571S, RTC626741S, RTC626744S, RTC600227S, RTC600446S, RTC600738S, RTC602429S, RTC602521S, RTC602532S, RTC602562S, RTC602581S, RTC602606S, RTC602647S, RTC602760S, RTC603157S, RTC604487S, RTC604489S, RTC604490S, RTC604517S, RTC604868S, RTC604869S, RTC604870S, RTC604873S, RTC604994S, RTC605153S, RTC605262S, RTC605346S, RTC605488S, RTC607041S, RTC607045S, RTC607227S, RTC607784S, RTC608747S, RTC608782S, RTC608850S, RTC608853S, RTC608856S, RTC609927S, RTC609929S, RTC610185S, RTC610675S, RTC611736S, RTC613746S, RTC613747S, RTC614222S, RTC600881S, RTC607799S, RTC608889S, RTC610967S, RTC611115S, RTC612552S, RTC612623S, RTC612697S, RTC613590S, RTC609631S, RTC609633S, RTC609635S, RTC605332S, RTC610110S, RTC613190S, RTC608980S, RTC622624S, RTC600052S, RTC600531S, RTC600539S, RTC600671S, RTC600679S, RTC600761S, RTC600783S, RTC600834S, RTC600859S, RTC600874S, RTC600889S, RTC602364S, RTC602365S, RTC602378S, RTC602435S, RTC602728S, RTC603671S, RTC603674S, RTC603687S, RTC607556S, RTC609093S, RTC…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1779-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1779-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; 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 00763000178093, Lot Serial Numbers: RTC605498S, RTC605500S, RTC605501S, RTC605502S, RTC607884S, RTC607885S, RTC608196S, RTC608199S, RTC608200S, RTC610884S, RTC610885S, RTC610887S, RTC610889S, RTC610890S, RTC610892S, RTC626989S, RTC626991S, RTC626992S, RTC626996S, RTC604820S, RTC605664S, RTC606411S, RTC606605S, RTC613019S, RTC613629S, RTC614078S, RTC612708S, RTC614277S, RTC611123S, RTC611127S, RTC611128S, RTC613158S, RTC613159S, RTC613160S, RTC613162S, RTC613164S, RTC613165S, RTC613166S, RTC626776S, RTC626778S, RTC626780S, RTC612365S, RTC612540S, RTC612629S, RTC614220S, RTC600235S, RTC600300S, RTC600381S, RTC600573S, RTC602541S, RTC602726S, RTC605274S, RTC605795S, RTC607215S, RTC607469S, RTC608981S, RTC609490S, RTC610107S, RTC610867S, RTC613560S, RTC614081S, RTC600433S, RTC600555S, RTC600556S, RTC600576S, RTC600703S, RTC604519S, RTC605238S, RTC605983S, RTC606093S, RTC606096S, RTC607001S, RTC607069S, RTC607165S, RTC607228S, RTC607497S, RTC609933S, RTC609934S, RTC614263S, RTC616913S, RTC626571S, RTC626741S, RTC626744S, RTC600227S, RTC600446S, RTC600738S, RTC602429S, RTC602521S, RTC602532S, RTC602562S, RTC602581S, RTC602606S, RTC602647S, RTC602760S, RTC603157S, RTC604487S, RTC604489S, RTC604490S, RTC604517S, RTC604868S, RTC604869S, RTC604870S, RTC604873S, RTC604994S, RTC605153S, RTC605262S, RTC605346S, RTC605488S, RTC6…
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-1779-2023 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.