ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1714-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; 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: ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1714-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1714-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1714-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1714-2023
      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 00643169443419, Lot Serial Numbers: PGZ624363S, PGZ631078S, PGZ638449S, PGZ638465S, PGZ623851S, PGZ645877S, PGZ621671S, PGZ621673S, PGZ623094S, PGZ623561S, PGZ623984S, PGZ623985S, PGZ623986S, PGZ623991S, PGZ624447S, PGZ626933S, PGZ626995S, PGZ627005S, PGZ627071S, PGZ629198S, PGZ629204S, PGZ629217S, PGZ631034S, PGZ631035S, PGZ631036S, PGZ631037S, PGZ633073S, PGZ633357S, PGZ633680S, PGZ635203S, PGZ635731S, PGZ635749S, PGZ635812S, PGZ635815S, PGZ635820S, PGZ637440S, PGZ637885S, PGZ637919S, PGZ637947S, PGZ637950S, PGZ638090S, PGZ638096S, PGZ638463S, PGZ641070S, PGZ641071S, PGZ641072S, PGZ641083S, PGZ641140S, PGZ641168S, PGZ641651S, PGZ641687S, PGZ642430S, PGZ643962S, PGZ645328S, PGZ622752S, PGZ626967S, PGZ629552S, PGZ630964S, PGZ631210S, PGZ632646S, PGZ637386S, PGZ641102S, PGZ643196S, PGZ644010S, PGZ629356S, PGZ632534S, PGZ636328S, PGZ636330S, PGZ637349S, PGZ638180S, PGZ638396S, PGZ641545S, PGZ641547S, PGZ623932S, PGZ624470S, PGZ629461S, PGZ630997S, PGZ631127S, PGZ636208S, PGZ638240S, PGZ640023S, PGZ641657S, PGZ641677S, PGZ632771S, PGZ630319S, PGZ637994S, PGZ622780S, PGZ622781S, PGZ624036S, PGZ627292S, PGZ628782S, PGZ629050S, PGZ631254S, PGZ633614S, PGZ638098S, PGZ638275S, PGZ638285S, PGZ640025S, PGZ641095S, PGZ641108S, PGZ642879S, PGZ629852S, PGZ630137S, PGZ632260S, PGZ632544S, PGZ633391S, PGZ636391S, PGZ636395S, PGZ637895S, PGZ638445S, PGZ641662S, PGZ643042S, PGZ624374S, PGZ628984S, PGZ640903S, PGZ641175S, PGZ643167S, PGZ621685S, PGZ623066S, PGZ623584S, PGZ623887S, PGZ624094S, PGZ626396S, PGZ629723S, PGZ629975S, PGZ631130S, PGZ631221S, PGZ632933S, PGZ633124S, PGZ635790S, PGZ636185S, PGZ636403S, PGZ637550S, PGZ637913S, PGZ638388S, PGZ638413S, PGZ641093S, PGZ641117S, PGZ641616S, PGZ642731S, PGZ642972S, PGZ643246S, PGZ643264S, PGZ643586S, PGZ644016S, PGZ623026S, PGZ626404S, PGZ629092S, PGZ635756S, PGZ637557S, PGZ637929S, PGZ641225S, PGZ643217S, PGZ639157S, PGZ642489S, PGZ642915S, PGZ643259S, PGZ623938S, PGZ630794S, PGZ632749S, PGZ633582S, PGZ637505S, PGZ638191S, PGZ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1714-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1714-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; 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 00643169443419, Lot Serial Numbers: PGZ624363S, PGZ631078S, PGZ638449S, PGZ638465S, PGZ623851S, PGZ645877S, PGZ621671S, PGZ621673S, PGZ623094S, PGZ623561S, PGZ623984S, PGZ623985S, PGZ623986S, PGZ623991S, PGZ624447S, PGZ626933S, PGZ626995S, PGZ627005S, PGZ627071S, PGZ629198S, PGZ629204S, PGZ629217S, PGZ631034S, PGZ631035S, PGZ631036S, PGZ631037S, PGZ633073S, PGZ633357S, PGZ633680S, PGZ635203S, PGZ635731S, PGZ635749S, PGZ635812S, PGZ635815S, PGZ635820S, PGZ637440S, PGZ637885S, PGZ637919S, PGZ637947S, PGZ637950S, PGZ638090S, PGZ638096S, PGZ638463S, PGZ641070S, PGZ641071S, PGZ641072S, PGZ641083S, PGZ641140S, PGZ641168S, PGZ641651S, PGZ641687S, PGZ642430S, PGZ643962S, PGZ645328S, PGZ622752S, PGZ626967S, PGZ629552S, PGZ630964S, PGZ631210S, PGZ632646S, PGZ637386S, PGZ641102S, PGZ643196S, PGZ644010S, PGZ629356S, PGZ632534S, PGZ636328S, PGZ636330S, PGZ637349S, PGZ638180S, PGZ638396S, PGZ641545S, PGZ641547S, PGZ623932S, PGZ624470S, PGZ629461S, PGZ630997S, PGZ631127S, PGZ636208S, PGZ638240S, PGZ640023S, PGZ641657S, PGZ641677S, PGZ632771S, PGZ630319S, PGZ637994S, PGZ622780S, PGZ622781S, PGZ624036S, PGZ627292S, PGZ628782S, PGZ629050S, PGZ631254S, PGZ633614S, PGZ638098S, PGZ638275S, PGZ638285S, PGZ640025S, PGZ641095S, PGZ641108S, PGZ642879S, PGZ629852S, PGZ630137S, PGZ632260S, PGZ632544S, PGZ633391S, PGZ636391S, PGZ636395S…
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-1714-2023 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.