CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1766-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; 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 DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1766-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1766-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1766-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1766-2023
      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 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK607156S, RPK607510S, RPK606721S, RPK606379S, RPK606753S, RPK603895S, RPK607997S, RPK608001S, RPK608115S, RPK602608S, RPK602842S, RPK602915S, RPK603155S, RPK603438S, RPK603475S, RPK604209S, RPK604230S, RPK604885S, RPK605001S, RPK605994S, RPK606046S, RPK606664S, RPK607134S, RPK608665S, RPK604002S, RPK604373S, RPK605499S, RPK605680S, RPK603963S, RPK607543S, RPK607544S, RPK607943S, RPK608088S, RPK608203S, RPK607149S, RPK607416S, RPK607418S, RPK607615S, RPK608212S, RPK608297S, RPK608298S, RPK609062S, RPK604646S, RPK605555S, RPK605685S, RPK606797S, RPK604171S, RPK605262S, RPK605291S, RPK605292S, RPK606475S, RPK607086S, RPK603372S, RPK603375S, RPK603380S, RPK603962S, RPK604174S, RPK604351S, RPK604536S, RPK604651S, RPK604654S, RPK604869S, RPK604972S, RPK604973S, RPK605109S, RPK605214S, RPK605233S, RPK605272S, RPK606024S, RPK606053S, RPK606141S, RPK606473S, RPK606792S, RPK606817S, RPK606853S, RPK607088S, RPK607422S, RPK607441S, RPK607442S, RPK607443S, RPK607620S, RPK607647S, RPK607857S, RPK607865S, RPK607972S, RPK608102S, RPK608939S, RPK604642S, RPK604644S, RPK604989S, RPK607684S, RPK608101S, RPK608890S, RPK603423S, RPK603908S, RPK604177S, RPK604228S, RPK604660S, RPK604981S, RPK605848S, RPK606143S, RPK606525S, RPK606535S, RPK607423S, RPK607911S, RPK607917S, RPK607918S, RPK604191S, RPK606048S, RPK606472S, RPK606793S, RPK606813S, RPK606816S, RPK607922S, RPK604227S, RPK604353S, RPK604630S, RPK605297S, RPK606819S, RPK606880S, RPK607479S, RPK604631S, RPK604649S, RPK606045S, RPK606047S, RPK604183S, RPK607541S, RPK605294S, RPK605491S, RPK607420S, RPK607424S, RPK607916S, RPK604169S, RPK607617S, RPK604354S, RPK605972S, RPK607864S, RPK604337S, RPK606799S, RPK607862S, RPK607970S, RPK605255S, RPK606479S, RPK606795S, RPK603498S, RPK607111S, RPK605251S, RPK602530S, RPK602763S, RPK604901S, RPK605486S, RPK606302S, RPK606871S, RPK606924S, RPK607005S, RPK607012S, RPK602647S, RPK…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1766-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1766-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; 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 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK607156S, RPK607510S, RPK606721S, RPK606379S, RPK606753S, RPK603895S, RPK607997S, RPK608001S, RPK608115S, RPK602608S, RPK602842S, RPK602915S, RPK603155S, RPK603438S, RPK603475S, RPK604209S, RPK604230S, RPK604885S, RPK605001S, RPK605994S, RPK606046S, RPK606664S, RPK607134S, RPK608665S, RPK604002S, RPK604373S, RPK605499S, RPK605680S, RPK603963S, RPK607543S, RPK607544S, RPK607943S, RPK608088S, RPK608203S, RPK607149S, RPK607416S, RPK607418S, RPK607615S, RPK608212S, RPK608297S, RPK608298S, RPK609062S, RPK604646S, RPK605555S, RPK605685S, RPK606797S, RPK604171S, RPK605262S, RPK605291S, RPK605292S, RPK606475S, RPK607086S, RPK603372S, RPK603375S, RPK603380S, RPK603962S, RPK604174S, RPK604351S, RPK604536S, RPK604651S, RPK604654S, RPK604869S, RPK604972S, RPK604973S, RPK605109S, RPK605214S, RPK605233S, RPK605272S, RPK606024S, RPK606053S, RPK606141S, RPK606473S, RPK606792S, RPK606817S, RPK606853S, RPK607088S, RPK607422S, RPK607441S, RPK607442S, RPK607443S, RPK607620S, RPK607647S, RPK607857S, RPK607865S, RPK607972S, RPK608102S, RPK608939S, RPK604642S, RPK604644S, RPK604989S, RPK607684S, RPK608101S, RPK608890S, RPK603423S, RPK603908S, RPK604177S, RPK604228S, RPK604660S, RPK604981S, RPK605848S, RPK606143S, RPK606525S, RPK6065…
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-1766-2023 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.