CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1739-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; 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: CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1739-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1739-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1739-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1739-2023
      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 00643169720169, Lot Serial Numbers: BLG624311S, BLG624755S, BLG625177S, BLG625181S, BLG625182S, BLG625188S, BLG625193S, BLG625324S, BLG625325S, BLG625434S, BLG625596S, BLG625598S, BLG625606S, BLG625608S, BLG625636S, BLG625647S, BLG625702S, BLG625740S, BLG625741S, BLG625745S, BLG625962S, BLG626105S, BLG626141S, BLG624936S, BLG624987S, BLG624995S, BLG625164S, BLG625167S, BLG625168S, BLG625242S, BLG625247S, BLG625565S, BLG625566S, BLG625568S, BLG625573S, BLG625616S, BLG625619S, BLG625620S, BLG625624S, BLG625651S, BLG625653S, BLG625655S, BLG625656S, BLG625489S, BLG625612S, BLG625910S, BLG624312S, BLG625331S, BLG624790S, BLG624843S, BLG624880S, BLG624881S, BLG624878S, BLG625644S, BLG624773S, BLG625148S, BLG625224S, BLG624958S, BLG625000S, BLG624751S, BLG624884S, BLG624890S, BLG624895S, BLG624896S, BLG624901S, BLG625171S, BLG625173S, BLG625175S, BLG625197S, BLG625571S, BLG625597S, BLG625605S, BLG625626S, BLG625630S, BLG625705S, BLG625876S, BLG626149S, BLG625650S, BLG625631S, BLG625228S, BLG625243S, BLG624759S, BLG625953S, BLG624816S, BLG624819S, BLG624827S, BLG624863S, BLG624889S, BLG624792S, BLG624795S, BLG625013S, BLG625023S, BLG625025S, BLG625304S, BLG625308S, BLG625311S, BLG625312S, BLG625317S, BLG625318S, BLG625319S, BLG625320S, BLG625321S, BLG625323S, BLG625241S, BLG624874S, BLG625239S, BLG625225S, BLG624879S, BLG625220S, BLG624947S, BLG624952S, BLG624954S, BLG625001S, BLG625652S, BLG624750S, BLG624754S, BLG624761S, BLG624762S, BLG624763S, BLG624765S, BLG625189S, BLG625303S, BLG625751S, BLG625746S, BLG625756S, BLG625861S, BLG625730S, BLG625749S, BLG624968S, BLG624969S, BLG624979S, BLG624984S, BLG625215S, BLG625216S, BLG625218S, BLG625219S, BLG625238S, BLG625245S, BLG624988S, BLG625842S, BLG625868S, BLG625945S, BLG626037S, BLG624976S, BLG624977S, BLG625213S, BLG625240S, BLG626737S, BLG625172S, BLG625195S, BLG624885S, BLG624886S, BLG624899S, BLG625092S, BLG625185S, BLG625192S, BLG624999S, BLG625231S, BLG624778S, BLG624848S, BLG625196S, BLG625301S, BLG624927S, BLG…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1739-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1739-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; 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 00643169720169, Lot Serial Numbers: BLG624311S, BLG624755S, BLG625177S, BLG625181S, BLG625182S, BLG625188S, BLG625193S, BLG625324S, BLG625325S, BLG625434S, BLG625596S, BLG625598S, BLG625606S, BLG625608S, BLG625636S, BLG625647S, BLG625702S, BLG625740S, BLG625741S, BLG625745S, BLG625962S, BLG626105S, BLG626141S, BLG624936S, BLG624987S, BLG624995S, BLG625164S, BLG625167S, BLG625168S, BLG625242S, BLG625247S, BLG625565S, BLG625566S, BLG625568S, BLG625573S, BLG625616S, BLG625619S, BLG625620S, BLG625624S, BLG625651S, BLG625653S, BLG625655S, BLG625656S, BLG625489S, BLG625612S, BLG625910S, BLG624312S, BLG625331S, BLG624790S, BLG624843S, BLG624880S, BLG624881S, BLG624878S, BLG625644S, BLG624773S, BLG625148S, BLG625224S, BLG624958S, BLG625000S, BLG624751S, BLG624884S, BLG624890S, BLG624895S, BLG624896S, BLG624901S, BLG625171S, BLG625173S, BLG625175S, BLG625197S, BLG625571S, BLG625597S, BLG625605S, BLG625626S, BLG625630S, BLG625705S, BLG625876S, BLG626149S, BLG625650S, BLG625631S, BLG625228S, BLG625243S, BLG624759S, BLG625953S, BLG624816S, BLG624819S, BLG624827S, BLG624863S, BLG624889S, BLG624792S, BLG624795S, BLG625013S, BLG625023S, BLG625025S, BLG625304S, BLG625308S, BLG625311S, BLG625312S, BLG625317S, BLG625318S, BLG625319S, BLG625320S, BLG625321S, BLG625323S, BLG625241S, BLG624874S, BLG625239S, BLG625225S, BLG624879S,…
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-1739-2023 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.