CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1750-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; 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 DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1750-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1750-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1750-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1750-2023
      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 00643169720305, Lot Serial Numbers: BLZ604044S, BLZ604109S, BLZ603698S, BLZ603713S, BLZ603726S, BLZ603835S, BLZ604013S, BLZ604101S, BLZ603725S, BLZ604036S, BLZ604059S, BLZ603770S, BLZ604032S, BLZ603602S, BLZ603626S, BLZ604001S, BLZ603743S, BLZ604536S, BLZ603622S, BLZ604076S, BLZ604915S, BLZ604263S, BLZ603735S, BLZ603422S, BLZ603918S, BLZ604138S, BLZ603587S, BLZ603604S, BLZ603663S, BLZ603723S, BLZ603840S, BLZ604082S, BLZ604065S, BLZ604080S, BLZ604102S, BLZ603740S, BLZ603967S, BLZ604467S, BLZ603620S, BLZ603705S, BLZ603788S, BLZ603812S, BLZ603977S, BLZ603978S, BLZ603980S, BLZ604031S, BLZ604072S, BLZ604134S, BLZ604097S, BLZ603639S, BLZ603941S, BLZ604056S, BLZ603594S, BLZ603683S, BLZ603720S, BLZ603898S, BLZ603921S, BLZ603982S, BLZ603983S, BLZ604057S, BLZ604135S, BLZ604908S, BLZ603732S, BLZ603787S, BLZ604146S, BLZ603643S, BLZ603958S, BLZ604107S, BLZ603796S, BLZ603605S, BLZ603902S, BLZ604049S, BLZ603694S, BLZ604103S, BLZ603716S, BLZ604111S, BLZ604006S, BLZ604110S, BLZ604099S, BLZ603874S, BLZ603894S, BLZ604093S, BLZ603972S, BLZ603859S, BLZ603603S, BLZ603614S, BLZ603856S, BLZ604005S, BLZ603595S, BLZ603813S, BLZ603880S, BLZ603899S, BLZ604014S, BLZ604053S, BLZ604016S, BLZ604017S, BLZ603879S, BLZ604051S, BLZ603615S, BLZ603906S, BLZ604909S, BLZ603861S, BLZ604075S, BLZ604087S, BLZ604139S, BLZ604913S, BLZ603623S, BLZ603913S, BLZ603616S, BLZ603825S, BLZ603612S, BLZ603844S, BLZ603960S, BLZ603795S, BLZ603803S, BLZ603784S, BLZ604069S, BLZ603627S, BLZ603642S, BLZ603752S, BLZ603834S, BLZ603956S, BLZ603984S, BLZ603985S, BLZ603986S, BLZ603990S, BLZ603991S, BLZ603992S, BLZ604329S, BLZ604332S, BLZ603782S, BLZ604313S, BLZ604321S, BLZ604331S, BLZ604373S, BLZ604374S, BLZ604380S, BLZ604454S, BLZ603766S, BLZ603995S, BLZ603610S, BLZ604142S, BLZ604916S, BLZ603878S, BLZ603957S, BLZ603790S, BLZ603576S, BLZ604094S, BLZ603884S, BLZ603656S, BLZ603758S, BLZ604008S, BLZ604136S, BLZ603618S, BLZ603636S, BLZ604535S, BLZ603762S, BLZ603792S, BLZ603710S, BLZ603846S, BLZ603718S, BLZ603793S, BLZ603733S, BLZ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1750-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1750-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; 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 00643169720305, Lot Serial Numbers: BLZ604044S, BLZ604109S, BLZ603698S, BLZ603713S, BLZ603726S, BLZ603835S, BLZ604013S, BLZ604101S, BLZ603725S, BLZ604036S, BLZ604059S, BLZ603770S, BLZ604032S, BLZ603602S, BLZ603626S, BLZ604001S, BLZ603743S, BLZ604536S, BLZ603622S, BLZ604076S, BLZ604915S, BLZ604263S, BLZ603735S, BLZ603422S, BLZ603918S, BLZ604138S, BLZ603587S, BLZ603604S, BLZ603663S, BLZ603723S, BLZ603840S, BLZ604082S, BLZ604065S, BLZ604080S, BLZ604102S, BLZ603740S, BLZ603967S, BLZ604467S, BLZ603620S, BLZ603705S, BLZ603788S, BLZ603812S, BLZ603977S, BLZ603978S, BLZ603980S, BLZ604031S, BLZ604072S, BLZ604134S, BLZ604097S, BLZ603639S, BLZ603941S, BLZ604056S, BLZ603594S, BLZ603683S, BLZ603720S, BLZ603898S, BLZ603921S, BLZ603982S, BLZ603983S, BLZ604057S, BLZ604135S, BLZ604908S, BLZ603732S, BLZ603787S, BLZ604146S, BLZ603643S, BLZ603958S, BLZ604107S, BLZ603796S, BLZ603605S, BLZ603902S, BLZ604049S, BLZ603694S, BLZ604103S, BLZ603716S, BLZ604111S, BLZ604006S, BLZ604110S, BLZ604099S, BLZ603874S, BLZ603894S, BLZ604093S, BLZ603972S, BLZ603859S, BLZ603603S, BLZ603614S, BLZ603856S, BLZ604005S, BLZ603595S, BLZ603813S, BLZ603880S, BLZ603899S, BLZ604014S, BLZ604053S, BLZ604016S, BLZ604017S, BLZ603879S, BLZ604051S, BLZ603615S, BLZ603906S, BLZ604909S, BLZ603861S, BLZ604075S, BLZ604087S, BLZ604139S, BLZ604913S, BLZ603623S, BLZ603913S, BLZ603…
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-1750-2023 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.