ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1713-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; 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 DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1713-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1713-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1713-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1713-2023
      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 00643169837720, Lot Serial Numbers: CWB609778S, CWB609784S, CWB609523S, CWB603432S, CWB605718S, CWB601752S, CWB601945S, CWB601946S, CWB602803S, CWB605225S, CWB607387S, CWB609714S, CWB605552S, CWB601729S, CWB602371S, CWB603105S, CWB603660S, CWB603852S, CWB604726S, CWB605271S, CWB608325S, CWB609120S, CWB607821S, CWB607823S, CWB607829S, CWB607834S, CWB607881S, CWB607884S, CWB607885S, CWB607886S, CWB608671S, CWB608672S, CWB608675S, CWB608676S, CWB608677S, CWB608678S, CWB608680S, CWB608681S, CWB608683S, CWB608684S, CWB608686S, CWB608687S, CWB608690S, CWB608691S, CWB608692S, CWB608697S, CWB609222S, CWB609930S, CWB609931S, CWB607959S, CWB608041S, CWB608051S, CWB608052S, CWB608055S, CWB608064S, CWB608067S, CWB608068S, CWB608069S, CWB608073S, CWB608074S, CWB608075S, CWB608081S, CWB608084S, CWB608085S, CWB608088S, CWB608089S, CWB608095S, CWB608842S, CWB608843S, CWB608844S, CWB608845S, CWB608847S, CWB608848S, CWB608849S, CWB608851S, CWB608854S, CWB608855S, CWB608856S, CWB608857S, CWB608858S, CWB608859S, CWB608861S, CWB608862S, CWB608863S, CWB606447S, CWB606663S, CWB609802S, CWB607230S, CWB608732S, CWB608748S, CWB607378S, CWB607380S, CWB607395S, CWB607440S, CWB607442S, CWB610021S, CWB610035S, CWB607236S, CWB607237S, CWB607367S, CWB607375S, CWB607376S, CWB607381S, CWB607386S, CWB607392S, CWB607398S, CWB607428S, CWB609901S, CWB609965S, CWB606256S, CWB607181S, CWB607465S, CWB607921S, CWB607969S, CWB609090S, CWB609271S, CWB609556S, CWB609976S, CWB602597S, CWB603368S, CWB604048S, CWB605696S, CWB607729S, CWB601527S, CWB601653S, CWB601782S, CWB601797S, CWB602914S, CWB603179S, CWB604661S, CWB605363S, CWB605686S, CWB605820S, CWB606946S, CWB608144S, CWB608356S, CWB608824S, CWB601514S, CWB601659S, CWB601662S, CWB601673S, CWB602294S, CWB602471S, CWB602484S, CWB603769S, CWB603966S, CWB604134S, CWB604718S, CWB606274S, CWB606537S, CWB606811S, CWB607466S, CWB607485S, CWB608906S, CWB601855S, CWB602461S, CWB603372S, CWB603418S, CWB605625S, CWB608337S, CWB608370S, CWB608428S, CWB608875S, CWB…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1713-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1713-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; 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 00643169837720, Lot Serial Numbers: CWB609778S, CWB609784S, CWB609523S, CWB603432S, CWB605718S, CWB601752S, CWB601945S, CWB601946S, CWB602803S, CWB605225S, CWB607387S, CWB609714S, CWB605552S, CWB601729S, CWB602371S, CWB603105S, CWB603660S, CWB603852S, CWB604726S, CWB605271S, CWB608325S, CWB609120S, CWB607821S, CWB607823S, CWB607829S, CWB607834S, CWB607881S, CWB607884S, CWB607885S, CWB607886S, CWB608671S, CWB608672S, CWB608675S, CWB608676S, CWB608677S, CWB608678S, CWB608680S, CWB608681S, CWB608683S, CWB608684S, CWB608686S, CWB608687S, CWB608690S, CWB608691S, CWB608692S, CWB608697S, CWB609222S, CWB609930S, CWB609931S, CWB607959S, CWB608041S, CWB608051S, CWB608052S, CWB608055S, CWB608064S, CWB608067S, CWB608068S, CWB608069S, CWB608073S, CWB608074S, CWB608075S, CWB608081S, CWB608084S, CWB608085S, CWB608088S, CWB608089S, CWB608095S, CWB608842S, CWB608843S, CWB608844S, CWB608845S, CWB608847S, CWB608848S, CWB608849S, CWB608851S, CWB608854S, CWB608855S, CWB608856S, CWB608857S, CWB608858S, CWB608859S, CWB608861S, CWB608862S, CWB608863S, CWB606447S, CWB606663S, CWB609802S, CWB607230S, CWB608732S, CWB608748S, CWB607378S, CWB607380S, CWB607395S, CWB607440S, CWB607442S, CWB610021S, CWB610035S, CWB607236S, CWB607237S, CWB607367S, CWB607375S, CWB607376S, CWB607381S, CWB607386S, CWB607392S, CWB607398S, CWB607428S, CWB609901S, CWB…
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-1713-2023 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.