CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1768-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; 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 DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1768-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1768-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1768-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1768-2023
      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 00643169720695, Lot Serial numbers: RPG619037S, RPG608482S, RPG611787S, RPG619305S, RPG609628S, RPG622247S, RPG619130S, RPG623603S, RPG610818S, RPG616992S, RPG619816S, RPG624535S, RPG614089S, RPG619704S, RPG619714S, RPG623002S, RPG624602S, RPG607260S, RPG607434S, RPG607977S, RPG608232S, RPG608831S, RPG609415S, RPG609836S, RPG609911S, RPG610009S, RPG610345S, RPG611061S, RPG611302S, RPG611328S, RPG611598S, RPG611600S, RPG611606S, RPG611666S, RPG611667S, RPG611668S, RPG612610S, RPG612884S, RPG612885S, RPG613206S, RPG613239S, RPG613578S, RPG613655S, RPG614353S, RPG614407S, RPG614439S, RPG614898S, RPG615028S, RPG617792S, RPG617839S, RPG618125S, RPG618648S, RPG618809S, RPG618811S, RPG619226S, RPG619228S, RPG619555S, RPG619776S, RPG619888S, RPG619890S, RPG619891S, RPG620540S, RPG620563S, RPG621028S, RPG621106S, RPG621190S, RPG621228S, RPG621272S, RPG621395S, RPG621680S, RPG621722S, RPG621724S, RPG621725S, RPG621730S, RPG621743S, RPG622038S, RPG622041S, RPG622085S, RPG622532S, RPG622533S, RPG622881S, RPG622905S, RPG622984S, RPG623287S, RPG623393S, RPG623681S, RPG623684S, RPG623693S, RPG624227S, RPG624640S, RPG624641S, RPG624699S, RPG624702S, RPG625103S, RPG625298S, RPG625299S, RPG625307S, RPG625310S, RPG625343S, RPG625704S, RPG625915S, RPG625919S, RPG626152S, RPG626157S, RPG626198S, RPG626210S, RPG626396S, RPG626399S, RPG626402S, RPG626560S, RPG626605S, RPG626606S, RPG618474S, RPG618477S, RPG618499S, RPG618602S, RPG618603S, RPG618611S, RPG618616S, RPG618617S, RPG618618S, RPG618619S, RPG618620S, RPG618621S, RPG618623S, RPG618624S, RPG618625S, RPG618626S, RPG618636S, RPG618637S, RPG618639S, RPG618640S, RPG618642S, RPG618643S, RPG618646S, RPG618647S, RPG620107S, RPG620115S, RPG620118S, RPG620120S, RPG620122S, RPG620160S, RPG620165S, RPG620166S, RPG620171S, RPG620177S, RPG620179S, RPG620185S, RPG620186S, RPG620189S, RPG620194S, RPG620200S, RPG620202S, RPG620213S, RPG620258S, RPG620270S, RPG620272S, RPG623171S, RPG623176S, RPG623180S, RPG623183S, RPG623184S, RPG623193S, RPG…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1768-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1768-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; 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 00643169720695, Lot Serial numbers: RPG619037S, RPG608482S, RPG611787S, RPG619305S, RPG609628S, RPG622247S, RPG619130S, RPG623603S, RPG610818S, RPG616992S, RPG619816S, RPG624535S, RPG614089S, RPG619704S, RPG619714S, RPG623002S, RPG624602S, RPG607260S, RPG607434S, RPG607977S, RPG608232S, RPG608831S, RPG609415S, RPG609836S, RPG609911S, RPG610009S, RPG610345S, RPG611061S, RPG611302S, RPG611328S, RPG611598S, RPG611600S, RPG611606S, RPG611666S, RPG611667S, RPG611668S, RPG612610S, RPG612884S, RPG612885S, RPG613206S, RPG613239S, RPG613578S, RPG613655S, RPG614353S, RPG614407S, RPG614439S, RPG614898S, RPG615028S, RPG617792S, RPG617839S, RPG618125S, RPG618648S, RPG618809S, RPG618811S, RPG619226S, RPG619228S, RPG619555S, RPG619776S, RPG619888S, RPG619890S, RPG619891S, RPG620540S, RPG620563S, RPG621028S, RPG621106S, RPG621190S, RPG621228S, RPG621272S, RPG621395S, RPG621680S, RPG621722S, RPG621724S, RPG621725S, RPG621730S, RPG621743S, RPG622038S, RPG622041S, RPG622085S, RPG622532S, RPG622533S, RPG622881S, RPG622905S, RPG622984S, RPG623287S, RPG623393S, RPG623681S, RPG623684S, RPG623693S, RPG624227S, RPG624640S, RPG624641S, RPG624699S, RPG624702S, RPG625103S, RPG625298S, RPG625299S, RPG625307S, RPG625310S, RPG625343S, RPG625704S, RPG625915S, RPG625919S, RPG626152S, RPG626157S, RPG626198S, RPG626210S, RPG626396S, RPG626399S, RP…
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-1768-2023 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.