CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1757-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; 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 DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1757-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1757-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1757-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1757-2023
      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 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO603586S, RPO603863S, RPO601733S, RPO603715S, RPO601235S, RPO601389S, RPO601698S, RPO601771S, RPO602006S, RPO602325S, RPO602359S, RPO602456S, RPO602547S, RPO602630S, RPO602667S, RPO602723S, RPO602912S, RPO602956S, RPO603277S, RPO603281S, RPO603474S, RPO603611S, RPO604037S, RPO604118S, RPO604253S, RPO604259S, RPO604282S, RPO604326S, RPO604369S, RPO604405S, RPO604406S, RPO603440S, RPO603702S, RPO603703S, RPO604049S, RPO604050S, RPO604051S, RPO604073S, RPO603075S, RPO601669S, RPO601697S, RPO601763S, RPO602062S, RPO602101S, RPO602494S, RPO602703S, RPO602722S, RPO603071S, RPO603199S, RPO603211S, RPO603337S, RPO603351S, RPO603374S, RPO603645S, RPO603832S, RPO603958S, RPO604249S, RPO604448S, RPO601161S, RPO601166S, RPO601351S, RPO601519S, RPO601648S, RPO601993S, RPO602166S, RPO603371S, RPO603558S, RPO603585S, RPO603608S, RPO603644S, RPO603657S, RPO604149S, RPO604234S, RPO604396S, RPO604415S, RPO601299S, RPO603042S, RPO604021S, RPO601893S, RPO602016S, RPO603962S, RPO604147S, RPO604306S, RPO604347S, RPO601471S, RPO601485S, RPO601591S, RPO601680S, RPO601738S, RPO601973S, RPO602107S, RPO602217S, RPO602241S, RPO602411S, RPO602736S, RPO602831S, RPO602842S, RPO603193S, RPO603306S, RPO603466S, RPO603818S, RPO603960S, RPO603981S, RPO604136S, RPO604183S, RPO604207S, RPO604231S, RPO604404S, RPO604421S, RPO601711S, RPO602582S, RPO601419S, RPO603463S, RPO603992S, RPO604102S, RPO604015S, RPO603163S, RPO603865S, RPO604274S, RPO604340S, RPO604441S, RPO601607S, RPO601737S, RPO602510S, RPO603736S, RPO604250S, RPO603839S, RPO601660S, RPO602292S, RPO602742S, RPO603112S, RPO603192S, RPO603510S, RPO603636S, RPO603802S, RPO603834S, RPO603901S, RPO604424S, RPO601752S, RPO602979S, RPO603424S, RPO603561S, RPO603688S, RPO603931S, RPO601766S, RPO602074S, RPO602123S, RPO602491S, RPO601808S, RPO602213S, RPO602468S, RPO602495S, RPO602801S, RPO602978S, RPO603190S, RPO604018S, RPO601982S, RPO…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1757-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1757-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; 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 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO603586S, RPO603863S, RPO601733S, RPO603715S, RPO601235S, RPO601389S, RPO601698S, RPO601771S, RPO602006S, RPO602325S, RPO602359S, RPO602456S, RPO602547S, RPO602630S, RPO602667S, RPO602723S, RPO602912S, RPO602956S, RPO603277S, RPO603281S, RPO603474S, RPO603611S, RPO604037S, RPO604118S, RPO604253S, RPO604259S, RPO604282S, RPO604326S, RPO604369S, RPO604405S, RPO604406S, RPO603440S, RPO603702S, RPO603703S, RPO604049S, RPO604050S, RPO604051S, RPO604073S, RPO603075S, RPO601669S, RPO601697S, RPO601763S, RPO602062S, RPO602101S, RPO602494S, RPO602703S, RPO602722S, RPO603071S, RPO603199S, RPO603211S, RPO603337S, RPO603351S, RPO603374S, RPO603645S, RPO603832S, RPO603958S, RPO604249S, RPO604448S, RPO601161S, RPO601166S, RPO601351S, RPO601519S, RPO601648S, RPO601993S, RPO602166S, RPO603371S, RPO603558S, RPO603585S, RPO603608S, RPO603644S, RPO603657S, RPO604149S, RPO604234S, RPO604396S, RPO604415S, RPO601299S, RPO603042S, RPO604021S, RPO601893S, RPO602016S, RPO603962S, RPO604147S, RPO604306S, RPO604347S, RPO601471S, RPO601485S, RPO601591S, RPO601680S, RPO601738S, RPO601973S, RPO602107S, RPO602217S, RPO602241S, RPO602411S, RPO602736S, RPO602831S, RPO602842S, RPO603193S, RPO603306S, RPO603466S, RPO603818S, RPO603960S, RPO6039…
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-1757-2023 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.