CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1777-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; 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: CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1777-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1777-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1777-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1777-2023
      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 00763000178130, Lot Serial Numbers: RTG605297S, RTG605299S, RTG600588S, RTG601635S, RTG601691S, RTG601840S, RTG601857S, RTG602986S, RTG601966S, RTG601364S, RTG601621S, RTG600270S, RTG600554S, RTG601405S, RTG601699S, RTG601977S, RTG605270S, RTG600137S, RTG600138S, RTG600181S, RTG600271S, RTG600618S, RTG600620S, RTG600621S, RTG600622S, RTG600640S, RTG601395S, RTG601441S, RTG601681S, RTG601783S, RTG601896S, RTG601945S, RTG601948S, RTG602037S, RTG602040S, RTG602042S, RTG602047S, RTG602165S, RTG602166S, RTG602167S, RTG602340S, RTG605614S, RTG602039S, RTG602228S, RTG602306S, RTG602477S, RTG605996S, RTG605997S, RTG604903S, RTG600228S, RTG600332S, RTG601906S, RTG602441S, RTG605330S, RTG605332S, RTG605838S, RTG601643S, RTG606091S, RTG600317S, RTG600255S, RTG600467S, RTG604871S, RTG605042S, RTG605051S, RTG606010S, RTG601452S, RTG602204S, RTG604466S, RTG600411S, RTG600412S, RTG600465S, RTG600517S, RTG602559S, RTG602561S, RTG602563S, RTG602565S, RTG602566S, RTG602569S, RTG602571S, RTG602573S, RTG603385S, RTG603386S, RTG603400S, RTG603404S, RTG605218S, RTG601409S, RTG601410S, RTG601525S, RTG601863S, RTG601870S, RTG603636S, RTG603637S, RTG603684S, RTG605663S, RTG601684S, RTG600188S, RTG601614S, RTG602242S, RTG600594S, RTG600612S, RTG601853S, RTG602197S, RTG600663S, RTG601900S, RTG601937S, RTG603003S, RTG600478S, RTG600514S, RTG600550S, RTG600592S, RTG601343S, RTG601396S, RTG601400S, RTG601514S, RTG601688S, RTG601697S, RTG601873S, RTG601881S, RTG602215S, RTG602524S, RTG602980S, RTG602981S, RTG602434S, RTG601439S, RTG602190S, RTG600374S, RTG600653S, RTG602158S, RTG602240S, RTG602472S, RTG602474S, RTG602893S, RTG602897S, RTG602898S, RTG604872S, RTG605326S, RTG605327S, RTG605328S, RTG605329S, RTG605696S, RTG600563S, RTG601913S, RTG600264S, RTG600575S, RTG601600S, RTG601597S, RTG601617S, RTG601671S, RTG601687S, RTG601698S, RTG602533S, RTG602752S, RTG602760S, RTG602944S, RTG605214S, RTG605217S, RTG606083S, RTG606084S, RTG602882S, RTG602883S, RTG603008S, RTG603049S, RTG602966S, RTG…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1777-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1777-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; 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 00763000178130, Lot Serial Numbers: RTG605297S, RTG605299S, RTG600588S, RTG601635S, RTG601691S, RTG601840S, RTG601857S, RTG602986S, RTG601966S, RTG601364S, RTG601621S, RTG600270S, RTG600554S, RTG601405S, RTG601699S, RTG601977S, RTG605270S, RTG600137S, RTG600138S, RTG600181S, RTG600271S, RTG600618S, RTG600620S, RTG600621S, RTG600622S, RTG600640S, RTG601395S, RTG601441S, RTG601681S, RTG601783S, RTG601896S, RTG601945S, RTG601948S, RTG602037S, RTG602040S, RTG602042S, RTG602047S, RTG602165S, RTG602166S, RTG602167S, RTG602340S, RTG605614S, RTG602039S, RTG602228S, RTG602306S, RTG602477S, RTG605996S, RTG605997S, RTG604903S, RTG600228S, RTG600332S, RTG601906S, RTG602441S, RTG605330S, RTG605332S, RTG605838S, RTG601643S, RTG606091S, RTG600317S, RTG600255S, RTG600467S, RTG604871S, RTG605042S, RTG605051S, RTG606010S, RTG601452S, RTG602204S, RTG604466S, RTG600411S, RTG600412S, RTG600465S, RTG600517S, RTG602559S, RTG602561S, RTG602563S, RTG602565S, RTG602566S, RTG602569S, RTG602571S, RTG602573S, RTG603385S, RTG603386S, RTG603400S, RTG603404S, RTG605218S, RTG601409S, RTG601410S, RTG601525S, RTG601863S, RTG601870S, RTG603636S, RTG603637S, RTG603684S, RTG605663S, RTG601684S, RTG600188S, RTG601614S, RTG602242S, RTG600594S, RTG600612S, RTG601853S, RTG602197S, RTG600663S, RTG601900S, RTG601937S, RTG603003S, RTG600478S, RTG600514S, RTG600550…
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-1777-2023 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.