CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1765-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; 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 DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1765-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1765-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1765-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1765-2023
      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 00643169837645, Lot Serial numbers: RPQ605053S, RPQ606292S, RPQ605067S, RPQ605093S, RPQ601699S, RPQ605875S, RPQ605881S, RPQ601451S, RPQ602698S, RPQ605503S, RPQ606300S, RPQ601185S, RPQ601351S, RPQ601948S, RPQ601950S, RPQ602093S, RPQ602202S, RPQ602212S, RPQ602402S, RPQ602403S, RPQ602595S, RPQ602960S, RPQ602961S, RPQ602985S, RPQ603049S, RPQ603082S, RPQ603318S, RPQ603408S, RPQ603450S, RPQ605289S, RPQ606079S, RPQ603112S, RPQ603355S, RPQ603428S, RPQ604101S, RPQ604644S, RPQ602479S, RPQ603775S, RPQ604354S, RPQ604567S, RPQ605754S, RPQ605514S, RPQ605535S, RPQ603729S, RPQ605540S, RPQ603758S, RPQ604571S, RPQ605118S, RPQ602683S, RPQ602692S, RPQ602715S, RPQ603495S, RPQ603504S, RPQ603555S, RPQ603644S, RPQ603647S, RPQ604572S, RPQ604621S, RPQ604622S, RPQ604684S, RPQ604686S, RPQ604777S, RPQ604953S, RPQ605095S, RPQ605164S, RPQ605353S, RPQ605428S, RPQ602526S, RPQ602527S, RPQ602702S, RPQ603503S, RPQ604660S, RPQ604880S, RPQ604892S, RPQ604942S, RPQ604951S, RPQ605209S, RPQ602359S, RPQ602686S, RPQ602740S, RPQ604375S, RPQ602680S, RPQ602720S, RPQ602365S, RPQ604944S, RPQ603730S, RPQ604712S, RPQ605182S, RPQ604730S, RPQ602700S, RPQ602713S, RPQ602721S, RPQ604311S, RPQ604941S, RPQ604532S, RPQ602043S, RPQ602834S, RPQ603511S, RPQ603931S, RPQ604691S, RPQ605315S, RPQ603657S, RPQ603726S, RPQ604957S, RPQ605526S, RPQ602494S, RPQ605547S, RPQ602706S, RPQ604873S, RPQ603732S, RPQ603733S, RPQ603531S, RPQ605548S, RPQ601399S, RPQ601363S, RPQ601475S, RPQ601503S, RPQ601784S, RPQ601787S, RPQ601820S, RPQ601876S, RPQ602078S, RPQ602082S, RPQ602274S, RPQ602487S, RPQ603279S, RPQ603404S, RPQ604017S, RPQ605706S, RPQ606168S, RPQ601353S, RPQ601372S, RPQ601456S, RPQ601907S, RPQ602005S, RPQ602099S, RPQ602767S, RPQ603226S, RPQ604295S, RPQ604758S, RPQ605107S, RPQ605468S, RPQ605617S, RPQ606271S, RPQ606394S, RPQ601228S, RPQ601207S, RPQ602303S, RPQ602651S, RPQ603335S, RPQ605242S, RPQ606182S, RPQ606349S, RPQ606446S, RPQ604562S, RPQ601663S, RPQ601879S, RPQ602206S, RPQ602275S, RPQ602562S, RPQ602823S, RPQ603719S, RPQ603837S, RPQ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1765-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1765-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; 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 00643169837645, Lot Serial numbers: RPQ605053S, RPQ606292S, RPQ605067S, RPQ605093S, RPQ601699S, RPQ605875S, RPQ605881S, RPQ601451S, RPQ602698S, RPQ605503S, RPQ606300S, RPQ601185S, RPQ601351S, RPQ601948S, RPQ601950S, RPQ602093S, RPQ602202S, RPQ602212S, RPQ602402S, RPQ602403S, RPQ602595S, RPQ602960S, RPQ602961S, RPQ602985S, RPQ603049S, RPQ603082S, RPQ603318S, RPQ603408S, RPQ603450S, RPQ605289S, RPQ606079S, RPQ603112S, RPQ603355S, RPQ603428S, RPQ604101S, RPQ604644S, RPQ602479S, RPQ603775S, RPQ604354S, RPQ604567S, RPQ605754S, RPQ605514S, RPQ605535S, RPQ603729S, RPQ605540S, RPQ603758S, RPQ604571S, RPQ605118S, RPQ602683S, RPQ602692S, RPQ602715S, RPQ603495S, RPQ603504S, RPQ603555S, RPQ603644S, RPQ603647S, RPQ604572S, RPQ604621S, RPQ604622S, RPQ604684S, RPQ604686S, RPQ604777S, RPQ604953S, RPQ605095S, RPQ605164S, RPQ605353S, RPQ605428S, RPQ602526S, RPQ602527S, RPQ602702S, RPQ603503S, RPQ604660S, RPQ604880S, RPQ604892S, RPQ604942S, RPQ604951S, RPQ605209S, RPQ602359S, RPQ602686S, RPQ602740S, RPQ604375S, RPQ602680S, RPQ602720S, RPQ602365S, RPQ604944S, RPQ603730S, RPQ604712S, RPQ605182S, RPQ604730S, RPQ602700S, RPQ602713S, RPQ602721S, RPQ604311S, RPQ604941S, RPQ604532S, RPQ602043S, RPQ602834S, RPQ603511S, RPQ603931S, RPQ604691S, RPQ605315S, RPQ603657S, RPQ603726S, RPQ604957S, RPQ605526S, RPQ602494S, RPQ605547S, RPQ602706S, RPQ6048…
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-1765-2023 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.