CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1758-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; 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 DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1758-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1758-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1758-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1758-2023
      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 00643169720664, Lot Serial Numbers: RPD605666S, RPD602978S, RPD602979S, RPD603034S, RPD604592S, RPD601674S, RPD603271S, RPD604163S, RPD605225S, RPD604970S, RPD601851S, RPD602346S, RPD602637S, RPD603019S, RPD605081S, RPD605207S, RPD604558S, RPD604927S, RPD604980S, RPD601671S, RPD601672S, RPD601677S, RPD601678S, RPD602218S, RPD602277S, RPD602303S, RPD602369S, RPD602439S, RPD602443S, RPD602581S, RPD602724S, RPD602728S, RPD602781S, RPD602793S, RPD602910S, RPD602940S, RPD603033S, RPD603173S, RPD603180S, RPD603254S, RPD603677S, RPD603733S, RPD603756S, RPD603966S, RPD603967S, RPD604091S, RPD604124S, RPD604201S, RPD604897S, RPD605386S, RPD605444S, RPD605446S, RPD605524S, RPD605667S, RPD605679S, RPD605428S, RPD604405S, RPD604954S, RPD604941S, RPD605596S, RPD601962S, RPD602692S, RPD602918S, RPD602973S, RPD602982S, RPD605595S, RPD605601S, RPD603067S, RPD602895S, RPD604445S, RPD602694S, RPD604443S, RPD604552S, RPD605084S, RPD603878S, RPD602612S, RPD602015S, RPD602203S, RPD602244S, RPD602348S, RPD602512S, RPD602649S, RPD602813S, RPD602835S, RPD602924S, RPD603046S, RPD603061S, RPD603062S, RPD603483S, RPD603567S, RPD603785S, RPD603849S, RPD603850S, RPD603860S, RPD603870S, RPD603888S, RPD604408S, RPD604562S, RPD604598S, RPD604616S, RPD604823S, RPD604923S, RPD605011S, RPD605053S, RPD605395S, RPD605403S, RPD605624S, RPD605673S, RPD601592S, RPD603971S, RPD604019S, RPD604497S, RPD604806S, RPD604924S, RPD605172S, RPD605252S, RPD605645S, RPD603584S, RPD605643S, RPD602423S, RPD604221S, RPD601924S, RPD602113S, RPD602179S, RPD602635S, RPD602963S, RPD603087S, RPD603108S, RPD603310S, RPD604038S, RPD604062S, RPD604349S, RPD604412S, RPD604563S, RPD604795S, RPD604990S, RPD605006S, RPD605122S, RPD605124S, RPD605140S, RPD605267S, RPD605337S, RPD605588S, RPD605674S, RPD601625S, RPD602073S, RPD604042S, RPD604347S, RPD604727S, RPD602999S, RPD604462S, RPD605042S, RPD602526S, RPD604432S, RPD602723S, RPD603149S, RPD603672S, RPD605231S, RPD601933S, RPD602094S, RPD602872S, RPD603885S, RPD604355S, RPD…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1758-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1758-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; 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 00643169720664, Lot Serial Numbers: RPD605666S, RPD602978S, RPD602979S, RPD603034S, RPD604592S, RPD601674S, RPD603271S, RPD604163S, RPD605225S, RPD604970S, RPD601851S, RPD602346S, RPD602637S, RPD603019S, RPD605081S, RPD605207S, RPD604558S, RPD604927S, RPD604980S, RPD601671S, RPD601672S, RPD601677S, RPD601678S, RPD602218S, RPD602277S, RPD602303S, RPD602369S, RPD602439S, RPD602443S, RPD602581S, RPD602724S, RPD602728S, RPD602781S, RPD602793S, RPD602910S, RPD602940S, RPD603033S, RPD603173S, RPD603180S, RPD603254S, RPD603677S, RPD603733S, RPD603756S, RPD603966S, RPD603967S, RPD604091S, RPD604124S, RPD604201S, RPD604897S, RPD605386S, RPD605444S, RPD605446S, RPD605524S, RPD605667S, RPD605679S, RPD605428S, RPD604405S, RPD604954S, RPD604941S, RPD605596S, RPD601962S, RPD602692S, RPD602918S, RPD602973S, RPD602982S, RPD605595S, RPD605601S, RPD603067S, RPD602895S, RPD604445S, RPD602694S, RPD604443S, RPD604552S, RPD605084S, RPD603878S, RPD602612S, RPD602015S, RPD602203S, RPD602244S, RPD602348S, RPD602512S, RPD602649S, RPD602813S, RPD602835S, RPD602924S, RPD603046S, RPD603061S, RPD603062S, RPD603483S, RPD603567S, RPD603785S, RPD603849S, RPD603850S, RPD603860S, RPD603870S, RPD603888S, RPD604408S, RPD604562S, RPD604598S, RPD604616S, RPD604823S, RPD604923S, RPD605011S, RPD605053S, RPD605395S, RPD605403S, RPD605624S, RPD605673S, RPD6015…
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-1758-2023 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.