CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1754-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; 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 DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1754-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1754-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1754-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1754-2023
      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 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC205937H, RPC206296H, RPC206416H, RPC206665H, RPC207309H, RPC207864H, RPC208393H, RPC209253H, RPC209691H, RPC209707H, RPC209745H, RPC209762H, RPC209847H, RPC209918H, RPC209843H, RPC203399H, RPC204295H, RPC202725H, RPC207338H, RPC204122H, RPC210083H, RPC207179H, RPC207493H, RPC207715H, RPC208839H, RPC210208H, RPC210209H, RPC210279H, RPC202502H, RPC206685H, RPC207835H, RPC202337H, RPC203913H, RPC206604H, RPC206605H, RPC206608H, RPC206609H, RPC207319H, RPC207608H, RPC209946H, RPC207476H, RPC208004H, RPC205236H, RPC207257H, RPC202491H, RPC202610H, RPC203628H, RPC203989H, RPC204238H, RPC204412H, RPC204523H, RPC205585H, RPC210162H, RPC202353H, RPC202434H, RPC202549H, RPC202947H, RPC203116H, RPC207575H, RPC202513H, RPC205862H, RPC207849H, RPC209388H, RPC210124H, RPC203780H, RPC204065H, RPC204066H, RPC210111H, RPC204504H, RPC203114H, RPC205516H, RPC205847H, RPC207025H, RPC207175H, RPC204556H, RPC207683H, RPC208161H, RPC208598H, RPC208896H, RPC209484H, RPC203280H, RPC203999H, RPC204866H, RPC204869H, RPC204871H, RPC204874H, RPC205657H, RPC205859H, RPC205860H, RPC206559H, RPC206713H, RPC207077H, RPC207577H, RPC208079H, RPC208366H, RPC209001H, RPC209018H, RPC209067H, RPC209386H, RPC202652H, RPC203629H, RPC203149H, RPC204932H, RPC206900H, RPC208153H, RPC203547H, RPC203646H, RPC203649H, RPC203650H, RPC203657H, RPC204651H, RPC204964H, RPC205201H, RPC205208H, RPC205243H, RPC205257H, RPC205324H, RPC205418H, RPC205450H, RPC205886H, RPC206253H, RPC206303H, RPC206363H, RPC206405H, RPC206570H, RPC207011H, RPC207013H, RPC207164H, RPC207189H, RPC207223H, RPC207299H, RPC207317H, RPC207734H, RPC207944H, RPC208173H, RPC208687H, RPC208727H, RPC209119H, RPC209560H, RPC209751H, RPC210185H, RPC203519H, RPC204384H, RPC204719H, RPC208146H, RPC205717H, RPC206158H, RPC207008H, RPC207445H, RPC207612H, RPC207680H, RPC207685H, RPC209617H, RPC209618H, RPC204693H, RPC205822H, RPC205823H, RPC…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1754-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1754-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; 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 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC205937H, RPC206296H, RPC206416H, RPC206665H, RPC207309H, RPC207864H, RPC208393H, RPC209253H, RPC209691H, RPC209707H, RPC209745H, RPC209762H, RPC209847H, RPC209918H, RPC209843H, RPC203399H, RPC204295H, RPC202725H, RPC207338H, RPC204122H, RPC210083H, RPC207179H, RPC207493H, RPC207715H, RPC208839H, RPC210208H, RPC210209H, RPC210279H, RPC202502H, RPC206685H, RPC207835H, RPC202337H, RPC203913H, RPC206604H, RPC206605H, RPC206608H, RPC206609H, RPC207319H, RPC207608H, RPC209946H, RPC207476H, RPC208004H, RPC205236H, RPC207257H, RPC202491H, RPC202610H, RPC203628H, RPC203989H, RPC204238H, RPC204412H, RPC204523H, RPC205585H, RPC210162H, RPC202353H, RPC202434H, RPC202549H, RPC202947H, RPC203116H, RPC207575H, RPC202513H, RPC205862H, RPC207849H, RPC209388H, RPC210124H, RPC203780H, RPC204065H, RPC204066H, RPC210111H, RPC204504H, RPC203114H, RPC205516H, RPC205847H, RPC207025H, RPC207175H, RPC204556H, RPC207683H, RPC208161H, RPC208598H, RPC208896H, RPC209484H, RPC203280H, RPC203999H, RPC204866H, RPC204869H, RPC204871H, RPC204874H, RPC205657H, RPC205859H, RPC205860H, RPC206559H, RPC206713H, RPC207077H, RPC207577H, RPC208079H, RPC208366H, RPC209001H, RPC209018H, RPC209067H, RPC209386H, RPC202652H, RPC203629H, RPC203149H, RPC20493…
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-1754-2023 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.