CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1752-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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 DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1752-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1752-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1752-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1752-2023
      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 00643169720183, Lot Serial Numbers: BLX611513S, BLX610983S, BLX610727S, BLX609800S, BLX610700S, BLX611193S, BLX611227S, BLX610459S, BLX613336S, BLX611231S, BLX610972S, BLX610821S, BLX611566S, BLX611238S, BLX610596S, BLX610449S, BLX610925S, BLX611306S, BLX610523S, BLX611147S, BLX611439S, BLX610568S, BLX611464S, BLX611546S, BLX611733S, BLX611813S, BLX612082S, BLX612083S, BLX612440S, BLX611069S, BLX611190S, BLX611293S, BLX610441S, BLX611452S, BLX610586S, BLX610739S, BLX611422S, BLX610467S, BLX610671S, BLX611002S, BLX611400S, BLX611499S, BLX611540S, BLX611542S, BLX611554S, BLX611561S, BLX611732S, BLX610299S, BLX611218S, BLX611398S, BLX611547S, BLX611549S, BLX611565S, BLX611613S, BLX610991S, BLX611110S, BLX611987S, BLX610490S, BLX611737S, BLX610446S, BLX610447S, BLX611511S, BLX611605S, BLX610480S, BLX611940S, BLX611927S, BLX610329S, BLX610451S, BLX610464S, BLX610989S, BLX611220S, BLX611515S, BLX611564S, BLX611611S, BLX611742S, BLX611923S, BLX610854S, BLX611391S, BLX611392S, BLX611931S, BLX611943S, BLX610340S, BLX611357S, BLX610393S, BLX610614S, BLX610931S, BLX610937S, BLX610978S, BLX611312S, BLX611366S, BLX611739S, BLX611962S, BLX611982S, BLX610624S, BLX611988S, BLX610470S, BLX611616S, BLX611201S, BLX611688S, BLX610744S, BLX610607S, BLX611683S, BLX611111S, BLX610476S, BLX610789S, BLX611524S, BLX610289S, BLX610484S, BLX610509S, BLX611370S, BLX611626S, BLX610516S, BLX611740S, BLX610392S, BLX611991S, BLX610386S, BLX610522S, BLX610678S, BLX610987S, BLX611390S, BLX610285S, BLX610320S, BLX610689S, BLX610809S, BLX610833S, BLX611082S, BLX611215S, BLX611423S, BLX611617S, BLX610726S, BLX611562S, BLX611120S, BLX611354S, BLX611535S, BLX611598S, BLX610304S, BLX610296S, BLX611463S, BLX611578S, BLX611689S, BLX611809S, BLX611690S, BLX611427S, BLX610439S, BLX611091S, BLX611247S, BLX611253S, BLX611254S, BLX611256S, BLX611260S, BLX610437S, BLX611917S, BLX611456S, BLX610794S, BLX610867S, BLX611095S, BLX611552S, BLX610305S, BLX610376S, BLX610973S, BLX611588S, BLX610697S, BLX610853S, BLX…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1752-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1752-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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 00643169720183, Lot Serial Numbers: BLX611513S, BLX610983S, BLX610727S, BLX609800S, BLX610700S, BLX611193S, BLX611227S, BLX610459S, BLX613336S, BLX611231S, BLX610972S, BLX610821S, BLX611566S, BLX611238S, BLX610596S, BLX610449S, BLX610925S, BLX611306S, BLX610523S, BLX611147S, BLX611439S, BLX610568S, BLX611464S, BLX611546S, BLX611733S, BLX611813S, BLX612082S, BLX612083S, BLX612440S, BLX611069S, BLX611190S, BLX611293S, BLX610441S, BLX611452S, BLX610586S, BLX610739S, BLX611422S, BLX610467S, BLX610671S, BLX611002S, BLX611400S, BLX611499S, BLX611540S, BLX611542S, BLX611554S, BLX611561S, BLX611732S, BLX610299S, BLX611218S, BLX611398S, BLX611547S, BLX611549S, BLX611565S, BLX611613S, BLX610991S, BLX611110S, BLX611987S, BLX610490S, BLX611737S, BLX610446S, BLX610447S, BLX611511S, BLX611605S, BLX610480S, BLX611940S, BLX611927S, BLX610329S, BLX610451S, BLX610464S, BLX610989S, BLX611220S, BLX611515S, BLX611564S, BLX611611S, BLX611742S, BLX611923S, BLX610854S, BLX611391S, BLX611392S, BLX611931S, BLX611943S, BLX610340S, BLX611357S, BLX610393S, BLX610614S, BLX610931S, BLX610937S, BLX610978S, BLX611312S, BLX611366S, BLX611739S, BLX611962S, BLX611982S, BLX610624S, BLX611988S, BLX610470S, BLX611616S, BLX611201S, BLX611688S, BLX610744S, BLX610607S, BLX611683S, BLX611111S, BLX610476S, BLX610789S, BLX611524S, BLX610289S, BLX610484S, B…
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-1752-2023 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.