CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1735-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; 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 DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1735-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1735-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1735-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1735-2023
      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 00643169217959; Lot Serial Numbers: BLJ622286S, BLJ622571S, BLJ622623S, BLJ622733S, BLJ622742S, BLJ622966S, BLJ624144S, BLJ622126S, BLJ624009S, BLJ622569S, BLJ623322S, BLJ622064S, BLJ622092S, BLJ623468S, BLJ623621S, BLJ623849S, BLJ624135S, BLJ622023S, BLJ623580S, BLJ624033S, BLJ623167S, BLJ623490S, BLJ622292S, BLJ622241S, BLJ623462S, BLJ623794S, BLJ623809S, BLJ624193S, BLJ621886S, BLJ621947S, BLJ622884S, BLJ623297S, BLJ623410S, BLJ623471S, BLJ624039S, BLJ621718S, BLJ622266S, BLJ622481S, BLJ622566S, BLJ622575S, BLJ622578S, BLJ622582S, BLJ622596S, BLJ622621S, BLJ622732S, BLJ622903S, BLJ622934S, BLJ622973S, BLJ623089S, BLJ623300S, BLJ623319S, BLJ623411S, BLJ623413S, BLJ623482S, BLJ623605S, BLJ623615S, BLJ623620S, BLJ623631S, BLJ623771S, BLJ623960S, BLJ622066S, BLJ622581S, BLJ623080S, BLJ623147S, BLJ621736S, BLJ621763S, BLJ622067S, BLJ622237S, BLJ622458S, BLJ622007S, BLJ622992S, BLJ623036S, BLJ623110S, BLJ623296S, BLJ623460S, BLJ623578S, BLJ624142S, BLJ622127S, BLJ622277S, BLJ623416S, BLJ623898S, BLJ623929S, BLJ621944S, BLJ622739S, BLJ622740S, BLJ622068S, BLJ622613S, BLJ623776S, BLJ623883S, BLJ624067S, BLJ624201S, BLJ623454S, BLJ624132S, BLJ622061S, BLJ622015S, BLJ622288S, BLJ622729S, BLJ624010S, BLJ622948S, BLJ621747S, BLJ622033S, BLJ622293S, BLJ624005S, BLJ622115S, BLJ624019S, BLJ624191S, BLJ623485S, BLJ622294S, BLJ621733S, BLJ622253S, BLJ623323S, BLJ624140S, BLJ623609S, BLJ621957S, BLJ622747S, BLJ622882S, BLJ622889S, BLJ622985S, BLJ623315S, BLJ621870S, BLJ624107S, BLJ622896S, BLJ623298S, BLJ623765S, BLJ623854S, BLJ621959S, BLJ622296S, BLJ621923S, BLJ623784S, BLJ622776S, BLJ622262S, BLJ622657S, BLJ623464S, BLJ623625S, BLJ621956S, BLJ622025S, BLJ622074S, BLJ622885S, BLJ623429S, BLJ624057S, BLJ624038S, BLJ624143S, BLJ623290S, BLJ623304S, BLJ623593S, BLJ624006S, BLJ624029S, BLJ622295S, BLJ623289S, BLJ623307S, BLJ624207S, BLJ623448S, BLJ624031S, BLJ622734S, BLJ623151S, BLJ623634S, BLJ624206S, BLJ622984S, BLJ623428S, BLJ622881S, BLJ621824S, BLJ622801S, BLJ623176S, BLJ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1735-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1735-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; 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 00643169217959; Lot Serial Numbers: BLJ622286S, BLJ622571S, BLJ622623S, BLJ622733S, BLJ622742S, BLJ622966S, BLJ624144S, BLJ622126S, BLJ624009S, BLJ622569S, BLJ623322S, BLJ622064S, BLJ622092S, BLJ623468S, BLJ623621S, BLJ623849S, BLJ624135S, BLJ622023S, BLJ623580S, BLJ624033S, BLJ623167S, BLJ623490S, BLJ622292S, BLJ622241S, BLJ623462S, BLJ623794S, BLJ623809S, BLJ624193S, BLJ621886S, BLJ621947S, BLJ622884S, BLJ623297S, BLJ623410S, BLJ623471S, BLJ624039S, BLJ621718S, BLJ622266S, BLJ622481S, BLJ622566S, BLJ622575S, BLJ622578S, BLJ622582S, BLJ622596S, BLJ622621S, BLJ622732S, BLJ622903S, BLJ622934S, BLJ622973S, BLJ623089S, BLJ623300S, BLJ623319S, BLJ623411S, BLJ623413S, BLJ623482S, BLJ623605S, BLJ623615S, BLJ623620S, BLJ623631S, BLJ623771S, BLJ623960S, BLJ622066S, BLJ622581S, BLJ623080S, BLJ623147S, BLJ621736S, BLJ621763S, BLJ622067S, BLJ622237S, BLJ622458S, BLJ622007S, BLJ622992S, BLJ623036S, BLJ623110S, BLJ623296S, BLJ623460S, BLJ623578S, BLJ624142S, BLJ622127S, BLJ622277S, BLJ623416S, BLJ623898S, BLJ623929S, BLJ621944S, BLJ622739S, BLJ622740S, BLJ622068S, BLJ622613S, BLJ623776S, BLJ623883S, BLJ624067S, BLJ624201S, BLJ623454S, BLJ624132S, BLJ622061S, BLJ622015S, BLJ622288S, BLJ622729S, BLJ624010S, BLJ622948S, BLJ621747S, BLJ622033S, BLJ622293S, BLJ624005S, BLJ622115S, BLJ624019S, BLJ624191S, BLJ623485S, BLJ622294S, BLJ6…
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-1735-2023 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.