CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1771-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; 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 DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1771-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1771-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1771-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1771-2023
      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 00643169837652, Lot Serial Numbers: RPR605458S, RPR606698S, RPR605664S, RPR602262S, RPR601954S, RPR602352S, RPR602691S, RPR602236S, RPR601128S, RPR601184S, RPR601760S, RPR603209S, RPR603275S, RPR603699S, RPR605742S, RPR605761S, RPR605767S, RPR605779S, RPR605784S, RPR605787S, RPR605804S, RPR605808S, RPR605811S, RPR605818S, RPR606116S, RPR606117S, RPR606122S, RPR606123S, RPR606127S, RPR606128S, RPR606138S, RPR606140S, RPR606272S, RPR606276S, RPR606278S, RPR606279S, RPR606285S, RPR606289S, RPR607179S, RPR607180S, RPR607181S, RPR607182S, RPR607183S, RPR607184S, RPR607185S, RPR607187S, RPR607188S, RPR607525S, RPR606331S, RPR607064S, RPR607604S, RPR607373S, RPR604676S, RPR605390S, RPR605391S, RPR607439S, RPR602589S, RPR602608S, RPR602612S, RPR602645S, RPR602882S, RPR602940S, RPR602941S, RPR602944S, RPR602946S, RPR602951S, RPR603067S, RPR603252S, RPR603254S, RPR603744S, RPR603758S, RPR603759S, RPR603891S, RPR603892S, RPR603894S, RPR604007S, RPR604025S, RPR604173S, RPR604233S, RPR604234S, RPR604235S, RPR604236S, RPR604237S, RPR604238S, RPR604302S, RPR604308S, RPR604320S, RPR604326S, RPR604354S, RPR604559S, RPR604560S, RPR604678S, RPR604679S, RPR604681S, RPR605666S, RPR605668S, RPR605899S, RPR605970S, RPR605971S, RPR606043S, RPR606048S, RPR606265S, RPR606308S, RPR606336S, RPR606342S, RPR606345S, RPR606348S, RPR606414S, RPR606497S, RPR606502S, RPR606714S, RPR606722S, RPR606910S, RPR606918S, RPR606960S, RPR607578S, RPR602225S, RPR602222S, RPR602233S, RPR602478S, RPR602191S, RPR602220S, RPR602234S, RPR602781S, RPR602482S, RPR602333S, RPR602275S, RPR602119S, RPR605950S, RPR606490S, RPR602221S, RPR605948S, RPR602786S, RPR602942S, RPR606489S, RPR602189S, RPR602338S, RPR601415S, RPR602190S, RPR602350S, RPR604759S, RPR606450S, RPR607603S, RPR605947S, RPR602092S, RPR602102S, RPR602212S, RPR602534S, RPR602570S, RPR602876S, RPR607115S, RPR607120S, RPR607127S, RPR604910S, RPR606952S, RPR607138S, RPR607276S, RPR601978S, RPR602013S, RPR602925S, RPR603298S, RPR603308S, RPR604397S, RPR…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1771-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1771-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; 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 00643169837652, Lot Serial Numbers: RPR605458S, RPR606698S, RPR605664S, RPR602262S, RPR601954S, RPR602352S, RPR602691S, RPR602236S, RPR601128S, RPR601184S, RPR601760S, RPR603209S, RPR603275S, RPR603699S, RPR605742S, RPR605761S, RPR605767S, RPR605779S, RPR605784S, RPR605787S, RPR605804S, RPR605808S, RPR605811S, RPR605818S, RPR606116S, RPR606117S, RPR606122S, RPR606123S, RPR606127S, RPR606128S, RPR606138S, RPR606140S, RPR606272S, RPR606276S, RPR606278S, RPR606279S, RPR606285S, RPR606289S, RPR607179S, RPR607180S, RPR607181S, RPR607182S, RPR607183S, RPR607184S, RPR607185S, RPR607187S, RPR607188S, RPR607525S, RPR606331S, RPR607064S, RPR607604S, RPR607373S, RPR604676S, RPR605390S, RPR605391S, RPR607439S, RPR602589S, RPR602608S, RPR602612S, RPR602645S, RPR602882S, RPR602940S, RPR602941S, RPR602944S, RPR602946S, RPR602951S, RPR603067S, RPR603252S, RPR603254S, RPR603744S, RPR603758S, RPR603759S, RPR603891S, RPR603892S, RPR603894S, RPR604007S, RPR604025S, RPR604173S, RPR604233S, RPR604234S, RPR604235S, RPR604236S, RPR604237S, RPR604238S, RPR604302S, RPR604308S, RPR604320S, RPR604326S, RPR604354S, RPR604559S, RPR604560S, RPR604678S, RPR604679S, RPR604681S, RPR605666S, RPR605668S, RPR605899S, RPR605970S, RPR605971S, RPR606043S, RPR606048S, RPR606265S, RPR606308S, RPR606336S, RPR606342S, RPR606345S, RPR606348S, RPR606414S, RPR6064…
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-1771-2023 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.