CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1762-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; 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 DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1762-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1762-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1762-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1762-2023
      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 00643169720718, Lot Serial Numbers: RPJ204877H, RPJ205009H, RPJ205996H, RPJ206294H, RPJ205851H, RPJ206501H, RPJ205969H, RPJ205051H, RPJ206429H, RPJ205893H, RPJ205344H, RPJ206237H, RPJ206208H, RPJ206032H, RPJ206082H, RPJ206104H, RPJ205080H, RPJ205234H, RPJ206059H, RPJ205438H, RPJ206376H, RPJ205287H, RPJ205509H, RPJ206342H, RPJ205891H, RPJ204872H, RPJ204899H, RPJ204933H, RPJ204973H, RPJ205142H, RPJ205777H, RPJ205989H, RPJ206295H, RPJ205059H, RPJ205148H, RPJ205732H, RPJ205873H, RPJ206504H, RPJ205500H, RPJ206357H, RPJ204876H, RPJ206359H, RPJ206369H, RPJ205623H, RPJ206218H, RPJ205743H, RPJ206172H, RPJ204917H, RPJ205981H, RPJ205041H, RPJ205073H, RPJ205235H, RPJ205246H, RPJ205279H, RPJ206045H, RPJ205880H, RPJ206050H, RPJ206207H, RPJ205049H, RPJ204888H, RPJ205038H, RPJ205039H, RPJ205047H, RPJ205053H, RPJ205054H, RPJ205333H, RPJ205334H, RPJ205349H, RPJ205420H, RPJ205471H, RPJ205510H, RPJ205593H, RPJ205717H, RPJ205727H, RPJ205982H, RPJ206074H, RPJ206186H, RPJ206234H, RPJ204891H, RPJ205317H, RPJ205918H, RPJ205410H, RPJ206238H, RPJ206500H, RPJ204998H, RPJ205089H, RPJ205560H, RPJ205770H, RPJ206389H, RPJ205871H, RPJ205872H, RPJ205876H, RPJ205957H, RPJ206198H, RPJ206199H, RPJ206418H, RPJ206499H, RPJ204956H, RPJ205488H, RPJ205784H, RPJ205964H, RPJ206004H, RPJ206308H, RPJ206480H, RPJ205339H, RPJ205425H, RPJ205427H, RPJ205428H, RPJ205468H, RPJ206159H, RPJ206178H, RPJ206368H, RPJ206485H, RPJ206486H, RPJ206355H, RPJ206483H, RPJ205003H, RPJ205006H, RPJ205716H, RPJ205845H, RPJ206012H, RPJ206210H, RPJ205525H, RPJ205800H, RPJ206391H, RPJ205647H, RPJ205745H, RPJ205911H, RPJ205933H, RPJ205980H, RPJ206253H, RPJ206382H, RPJ206409H, RPJ206487H, RPJ204978H, RPJ205114H, RPJ205545H, RPJ205823H, RPJ205910H, RPJ205961H, RPJ206038H, RPJ206069H, RPJ206166H, RPJ206273H, RPJ206311H, RPJ206315H, RPJ206383H, RPJ206466H, RPJ206516H, RPJ205436H, RPJ205763H, RPJ205976H, RPJ205061H, RPJ205563H, RPJ205771H, RPJ206107H, RPJ205485H, RPJ206399H, RPJ205091H, RPJ205514H, RPJ206408H, RPJ206009H, RPJ205296H, RPJ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1762-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1762-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; 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 00643169720718, Lot Serial Numbers: RPJ204877H, RPJ205009H, RPJ205996H, RPJ206294H, RPJ205851H, RPJ206501H, RPJ205969H, RPJ205051H, RPJ206429H, RPJ205893H, RPJ205344H, RPJ206237H, RPJ206208H, RPJ206032H, RPJ206082H, RPJ206104H, RPJ205080H, RPJ205234H, RPJ206059H, RPJ205438H, RPJ206376H, RPJ205287H, RPJ205509H, RPJ206342H, RPJ205891H, RPJ204872H, RPJ204899H, RPJ204933H, RPJ204973H, RPJ205142H, RPJ205777H, RPJ205989H, RPJ206295H, RPJ205059H, RPJ205148H, RPJ205732H, RPJ205873H, RPJ206504H, RPJ205500H, RPJ206357H, RPJ204876H, RPJ206359H, RPJ206369H, RPJ205623H, RPJ206218H, RPJ205743H, RPJ206172H, RPJ204917H, RPJ205981H, RPJ205041H, RPJ205073H, RPJ205235H, RPJ205246H, RPJ205279H, RPJ206045H, RPJ205880H, RPJ206050H, RPJ206207H, RPJ205049H, RPJ204888H, RPJ205038H, RPJ205039H, RPJ205047H, RPJ205053H, RPJ205054H, RPJ205333H, RPJ205334H, RPJ205349H, RPJ205420H, RPJ205471H, RPJ205510H, RPJ205593H, RPJ205717H, RPJ205727H, RPJ205982H, RPJ206074H, RPJ206186H, RPJ206234H, RPJ204891H, RPJ205317H, RPJ205918H, RPJ205410H, RPJ206238H, RPJ206500H, RPJ204998H, RPJ205089H, RPJ205560H, RPJ205770H, RPJ206389H, RPJ205871H, RPJ205872H, RPJ205876H, RPJ205957H, RPJ206198H, RPJ206199H, RPJ206418H, RPJ206499H, RPJ204956H, RPJ205488H, RPJ205784H, RPJ205964H, RPJ206004H, RPJ206308H, RPJ206480H, RPJ205339H, RPJ205425H, RPJ205427H, RPJ205428H, RPJ20546…
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-1762-2023 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.