CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1761-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; 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 DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1761-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1761-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1761-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1761-2023
      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 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV205665H, RPV205443H, RPV205510H, RPV204476H, RPV205107H, RPV204152H, RPV204326H, RPV204327H, RPV204329H, RPV203937H, RPV204831H, RPV204911H, RPV205343H, RPV205351H, RPV205497H, RPV205762H, RPV205763H, RPV205785H, RPV203840H, RPV204908H, RPV205661H, RPV203773H, RPV203795H, RPV203808H, RPV204568H, RPV205383H, RPV205713H, RPV205312H, RPV205849H, RPV204239H, RPV205251H, RPV203909H, RPV204821H, RPV205370H, RPV205812H, RPV205832H, RPV205093H, RPV204730H, RPV204741H, RPV204553H, RPV203983H, RPV205414H, RPV205597H, RPV205682H, RPV205541H, RPV204597H, RPV204711H, RPV205219H, RPV205645H, RPV205215H, RPV205056H, RPV203988H, RPV204130H, RPV204198H, RPV204610H, RPV205672H, RPV205843H, RPV205358H, RPV205484H, RPV205614H, RPV204042H, RPV204393H, RPV204418H, RPV204768H, RPV205338H, RPV205636H, RPV204270H, RPV205806H, RPV204735H, RPV204785H, RPV204806H, RPV205115H, RPV205117H, RPV205118H, RPV205120H, RPV205257H, RPV205259H, RPV205320H, RPV205337H, RPV205356H, RPV205384H, RPV205436H, RPV205442H, RPV205593H, RPV205756H, RPV205775H, RPV205811H, RPV203905H, RPV204228H, RPV204229H, RPV204681H, RPV204682H, RPV204959H, RPV205211H, RPV205288H, RPV205299H, RPV204872H, RPV203738H, RPV203780H, RPV203783H, RPV203787H, RPV203861H, RPV204026H, RPV204037H, RPV204128H, RPV204527H, RPV204535H, RPV204929H, RPV204930H, RPV204938H, RPV204941H, RPV204942H, RPV204950H, RPV204952H, RPV205372H, RPV205426H, RPV205430H, RPV205438H, RPV205787H, RPV205817H, RPV205835H, RPV204269H, RPV204612H, RPV205032H, RPV205086H, RPV205223H, RPV205252H, RPV204752H, RPV205185H, RPV205292H, RPV205534H, RPV205615H, RPV205638H, RPV205748H, RPV204015H, RPV204855H, RPV205220H, RPV205317H, RPV205757H, RPV205802H, RPV205826H, RPV203862H, RPV204890H, RPV205389H, RPV205407H, RPV204189H, RPV204201H, RPV204428H, RPV204589H, RPV204858H, RPV204894H, RPV205808H, RPV204755H, RPV205065H, RPV205385H, RPV204055H, RPV204803H, RPV…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1761-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1761-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; 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 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV205665H, RPV205443H, RPV205510H, RPV204476H, RPV205107H, RPV204152H, RPV204326H, RPV204327H, RPV204329H, RPV203937H, RPV204831H, RPV204911H, RPV205343H, RPV205351H, RPV205497H, RPV205762H, RPV205763H, RPV205785H, RPV203840H, RPV204908H, RPV205661H, RPV203773H, RPV203795H, RPV203808H, RPV204568H, RPV205383H, RPV205713H, RPV205312H, RPV205849H, RPV204239H, RPV205251H, RPV203909H, RPV204821H, RPV205370H, RPV205812H, RPV205832H, RPV205093H, RPV204730H, RPV204741H, RPV204553H, RPV203983H, RPV205414H, RPV205597H, RPV205682H, RPV205541H, RPV204597H, RPV204711H, RPV205219H, RPV205645H, RPV205215H, RPV205056H, RPV203988H, RPV204130H, RPV204198H, RPV204610H, RPV205672H, RPV205843H, RPV205358H, RPV205484H, RPV205614H, RPV204042H, RPV204393H, RPV204418H, RPV204768H, RPV205338H, RPV205636H, RPV204270H, RPV205806H, RPV204735H, RPV204785H, RPV204806H, RPV205115H, RPV205117H, RPV205118H, RPV205120H, RPV205257H, RPV205259H, RPV205320H, RPV205337H, RPV205356H, RPV205384H, RPV205436H, RPV205442H, RPV205593H, RPV205756H, RPV205775H, RPV205811H, RPV203905H, RPV204228H, RPV204229H, RPV204681H, RPV204682H, RPV204959H, RPV205211H, RPV205288H, RPV205299H, RPV204872H, RPV203738H, RPV203780H, RPV203783H, RPV203787H, RPV203861H, RPV20402…
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-1761-2023 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.