CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1749-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; 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 DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1749-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1749-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1749-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1749-2023
      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 00643169720367, Lot Serial Numbers: BLW607464S, BLW607601S, BLW607643S, BLW607705S, BLW607921S, BLW608132S, BLW608133S, BLW608134S, BLW608135S, BLW608235S, BLW608746S, BLW609769S, BLW606989S, BLW607809S, BLW607902S, BLW607917S, BLW607284S, BLW607004S, BLW607851S, BLW607173S, BLW607320S, BLW607015S, BLW607319S, BLW607257S, BLW607269S, BLW607346S, BLW607361S, BLW607031S, BLW607243S, BLW606959S, BLW607058S, BLW607285S, BLW607580S, BLW607394S, BLW607249S, BLW607505S, BLW607573S, BLW606999S, BLW607254S, BLW607835S, BLW607159S, BLW606948S, BLW606961S, BLW607044S, BLW607113S, BLW607292S, BLW607406S, BLW607498S, BLW607661S, BLW607758S, BLW607759S, BLW607865S, BLW607248S, BLW607866S, BLW607021S, BLW607598S, BLW607665S, BLW607823S, BLW607493S, BLW607001S, BLW607817S, BLW607841S, BLW607883S, BLW607747S, BLW608268S, BLW607287S, BLW607356S, BLW607440S, BLW607473S, BLW607636S, BLW607709S, BLW607943S, BLW606941S, BLW607330S, BLW607029S, BLW607205S, BLW607207S, BLW607818S, BLW607896S, BLW607847S, BLW606952S, BLW607639S, BLW607640S, BLW607209S, BLW607230S, BLW607859S, BLW607300S, BLW606991S, BLW607037S, BLW607252S, BLW607468S, BLW607477S, BLW607513S, BLW607863S, BLW607927S, BLW607946S, BLW607188S, BLW607268S, BLW607360S, BLW607412S, BLW607478S, BLW607602S, BLW607679S, BLW608772S, BLW609755S, BLW607064S, BLW607428S, BLW607613S, BLW607055S, BLW607169S, BLW606979S, BLW606932S, BLW606963S, BLW607041S, BLW607099S, BLW607104S, BLW607274S, BLW607275S, BLW607616S, BLW607617S, BLW607723S, BLW607807S, BLW606949S, BLW606967S, BLW607253S, BLW607299S, BLW607318S, BLW607711S, BLW606958S, BLW607701S, BLW607837S, BLW607879S, BLW607920S, BLW607514S, BLW607596S, BLW607547S, BLW607646S, BLW606945S, BLW606946S, BLW606993S, BLW607053S, BLW607304S, BLW607327S, BLW607604S, BLW607717S, BLW607293S, BLW607165S, BLW607298S, BLW607374S, BLW607649S, BLW607754S, BLW607432S, BLW607195S, BLW607641S, BLW607813S, BLW606929S, BLW607106S, BLW607164S, BLW607942S, BLW607683S, BLW607901S, BLW606997S, BLW607481S, BLW…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1749-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1749-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; 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 00643169720367, Lot Serial Numbers: BLW607464S, BLW607601S, BLW607643S, BLW607705S, BLW607921S, BLW608132S, BLW608133S, BLW608134S, BLW608135S, BLW608235S, BLW608746S, BLW609769S, BLW606989S, BLW607809S, BLW607902S, BLW607917S, BLW607284S, BLW607004S, BLW607851S, BLW607173S, BLW607320S, BLW607015S, BLW607319S, BLW607257S, BLW607269S, BLW607346S, BLW607361S, BLW607031S, BLW607243S, BLW606959S, BLW607058S, BLW607285S, BLW607580S, BLW607394S, BLW607249S, BLW607505S, BLW607573S, BLW606999S, BLW607254S, BLW607835S, BLW607159S, BLW606948S, BLW606961S, BLW607044S, BLW607113S, BLW607292S, BLW607406S, BLW607498S, BLW607661S, BLW607758S, BLW607759S, BLW607865S, BLW607248S, BLW607866S, BLW607021S, BLW607598S, BLW607665S, BLW607823S, BLW607493S, BLW607001S, BLW607817S, BLW607841S, BLW607883S, BLW607747S, BLW608268S, BLW607287S, BLW607356S, BLW607440S, BLW607473S, BLW607636S, BLW607709S, BLW607943S, BLW606941S, BLW607330S, BLW607029S, BLW607205S, BLW607207S, BLW607818S, BLW607896S, BLW607847S, BLW606952S, BLW607639S, BLW607640S, BLW607209S, BLW607230S, BLW607859S, BLW607300S, BLW606991S, BLW607037S, BLW607252S, BLW607468S, BLW607477S, BLW607513S, BLW607863S, BLW607927S, BLW607946S, BLW607188S, BLW607268S, BLW607360S, BLW607412S, BLW607478S, BLW607602S, BLW607679S, BLW608772S, BLW609755S, BLW607064S, BLW607428S, BLW607613S, BLW607…
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-1749-2023 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.