CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1737-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; 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 DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1737-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1737-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1737-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1737-2023
      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 00643169217966, Lot Serial Numbers: BLI613233S, BLI613324S, BLI613699S, BLI614038S, BLI614165S, BLI613293S, BLI613712S, BLI613772S, BLI614301S, BLI613871S, BLI614140S, BLI614826S, BLI612567S, BLI614031S, BLI613259S, BLI613417S, BLI614737S, BLI614194S, BLI614210S, BLI614604S, BLI613371S, BLI612853S, BLI612859S, BLI613234S, BLI613304S, BLI613305S, BLI613994S, BLI614312S, BLI614469S, BLI612711S, BLI612774S, BLI612954S, BLI613449S, BLI613588S, BLI613591S, BLI614002S, BLI614013S, BLI614290S, BLI614537S, BLI614600S, BLI612805S, BLI613296S, BLI614202S, BLI614460S, BLI613765S, BLI613867S, BLI614307S, BLI614462S, BLI614482S, BLI614593S, BLI612754S, BLI612627S, BLI612707S, BLI612922S, BLI613008S, BLI613255S, BLI613312S, BLI613592S, BLI613665S, BLI613874S, BLI614300S, BLI614304S, BLI614478S, BLI614550S, BLI612769S, BLI613229S, BLI613373S, BLI614302S, BLI614836S, BLI613865S, BLI612946S, BLI613750S, BLI614184S, BLI614577S, BLI613754S, BLI613758S, BLI612866S, BLI612961S, BLI614599S, BLI613275S, BLI613418S, BLI613649S, BLI613879S, BLI614325S, BLI612962S, BLI613272S, BLI614595S, BLI613243S, BLI613284S, BLI614472S, BLI612753S, BLI613334S, BLI613664S, BLI612828S, BLI614463S, BLI614487S, BLI614772S, BLI614781S, BLI612721S, BLI612752S, BLI613693S, BLI613790S, BLI612950S, BLI613294S, BLI613331S, BLI613332S, BLI614173S, BLI614535S, BLI614831S, BLI612781S, BLI612956S, BLI613231S, BLI612717S, BLI612902S, BLI614784S, BLI613992S, BLI612937S, BLI614227S, BLI612867S, BLI614167S, BLI613452S, BLI614000S, BLI614043S, BLI614316S, BLI614586S, BLI613336S, BLI613415S, BLI613689S, BLI614182S, BLI612917S, BLI612941S, BLI612952S, BLI614147S, BLI613239S, BLI614587S, BLI614467S, BLI614474S, BLI613222S, BLI614218S, BLI613300S, BLI612908S, BLI614764S, BLI612778S, BLI613728S, BLI614769S, BLI612584S, BLI612764S, BLI614003S, BLI614575S, BLI613307S, BLI613224S, BLI613502S, BLI614759S, BLI612576S, BLI612837S, BLI614180S, BLI612558S, BLI612773S, BLI614027S, BLI614477S, BLI614573S, BLI614024S, BLI614581S, BLI…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1737-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1737-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; 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 00643169217966, Lot Serial Numbers: BLI613233S, BLI613324S, BLI613699S, BLI614038S, BLI614165S, BLI613293S, BLI613712S, BLI613772S, BLI614301S, BLI613871S, BLI614140S, BLI614826S, BLI612567S, BLI614031S, BLI613259S, BLI613417S, BLI614737S, BLI614194S, BLI614210S, BLI614604S, BLI613371S, BLI612853S, BLI612859S, BLI613234S, BLI613304S, BLI613305S, BLI613994S, BLI614312S, BLI614469S, BLI612711S, BLI612774S, BLI612954S, BLI613449S, BLI613588S, BLI613591S, BLI614002S, BLI614013S, BLI614290S, BLI614537S, BLI614600S, BLI612805S, BLI613296S, BLI614202S, BLI614460S, BLI613765S, BLI613867S, BLI614307S, BLI614462S, BLI614482S, BLI614593S, BLI612754S, BLI612627S, BLI612707S, BLI612922S, BLI613008S, BLI613255S, BLI613312S, BLI613592S, BLI613665S, BLI613874S, BLI614300S, BLI614304S, BLI614478S, BLI614550S, BLI612769S, BLI613229S, BLI613373S, BLI614302S, BLI614836S, BLI613865S, BLI612946S, BLI613750S, BLI614184S, BLI614577S, BLI613754S, BLI613758S, BLI612866S, BLI612961S, BLI614599S, BLI613275S, BLI613418S, BLI613649S, BLI613879S, BLI614325S, BLI612962S, BLI613272S, BLI614595S, BLI613243S, BLI613284S, BLI614472S, BLI612753S, BLI613334S, BLI613664S, BLI612828S, BLI614463S, BLI614487S, BLI614772S, BLI614781S, BLI612721S, BLI612752S, BLI613693S, BLI613790S, BLI612950S, BLI613294S, BLI613331S, BLI613332S, BLI614173S, BLI614535S, BLI6…
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-1737-2023 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.