ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1711-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; 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 DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1711-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1711-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1711-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1711-2023
      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 00643169837713, Lot Serial Numbers: CWA218162H, CWA219897H, CWA221224H, CWA222730H, CWA223319H, CWA224001H, CWA230660H, CWA212204H, CWA215507H, CWA219655H, CWA228049H, CWA228101H, CWA230635H, CWA230642H, CWA213967H, CWA217145H, CWA220168H, CWA225093H, CWA229346H, CWA232234H, CWA215257H, CWA215420H, CWA221756H, CWA221922H, CWA222159H, CWA225001H, CWA225149H, CWA225777H, CWA227620H, CWA227845H, CWA228935H, CWA229962H, CWA231576H, CWA231578H, CWA213741H, CWA216957H, CWA223516H, CWA225894H, CWA231485H, CWA211463H, CWA211464H, CWA211465H, CWA211466H, CWA211467H, CWA211468H, CWA211470H, CWA214199H, CWA214200H, CWA214201H, CWA214203H, CWA214205H, CWA214208H, CWA214210H, CWA214211H, CWA214212H, CWA214213H, CWA217480H, CWA217481H, CWA217482H, CWA217483H, CWA217484H, CWA217485H, CWA220397H, CWA220400H, CWA220407H, CWA220408H, CWA222904H, CWA224042H, CWA226903H, CWA226919H, CWA230608H, CWA230609H, CWA230611H, CWA230612H, CWA217020H, CWA220851H, CWA224216H, CWA226111H, CWA230832H, CWA231351H, CWA220280H, CWA222986H, CWA223614H, CWA229484H, CWA218262H, CWA224443H, CWA212537H, CWA213744H, CWA214146H, CWA214362H, CWA215549H, CWA215657H, CWA216424H, CWA216460H, CWA216476H, CWA217621H, CWA217808H, CWA217987H, CWA218225H, CWA218288H, CWA219444H, CWA219446H, CWA219708H, CWA221001H, CWA222259H, CWA222260H, CWA222261H, CWA222264H, CWA222277H, CWA222283H, CWA222284H, CWA223476H, CWA223580H, CWA223581H, CWA223745H, CWA223967H, CWA224016H, CWA224056H, CWA224540H, CWA224722H, CWA225254H, CWA225353H, CWA225704H, CWA225717H, CWA225827H, CWA225937H, CWA226228H, CWA227114H, CWA227182H, CWA227264H, CWA227338H, CWA227350H, CWA227379H, CWA227807H, CWA227931H, CWA227988H, CWA228056H, CWA228536H, CWA228548H, CWA229501H, CWA229502H, CWA229519H, CWA229529H, CWA229542H, CWA230072H, CWA230073H, CWA230078H, CWA231365H, CWA231474H, CWA231821H, CWA232281H, CWA232415H, CWA215401H, CWA219187H, CWA211592H, CWA211593H, CWA212850H, CWA214296H, CWA217178H, CWA217183H, CWA220368H, CWA220371H, CWA223182H, CWA…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1711-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1711-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; 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 00643169837713, Lot Serial Numbers: CWA218162H, CWA219897H, CWA221224H, CWA222730H, CWA223319H, CWA224001H, CWA230660H, CWA212204H, CWA215507H, CWA219655H, CWA228049H, CWA228101H, CWA230635H, CWA230642H, CWA213967H, CWA217145H, CWA220168H, CWA225093H, CWA229346H, CWA232234H, CWA215257H, CWA215420H, CWA221756H, CWA221922H, CWA222159H, CWA225001H, CWA225149H, CWA225777H, CWA227620H, CWA227845H, CWA228935H, CWA229962H, CWA231576H, CWA231578H, CWA213741H, CWA216957H, CWA223516H, CWA225894H, CWA231485H, CWA211463H, CWA211464H, CWA211465H, CWA211466H, CWA211467H, CWA211468H, CWA211470H, CWA214199H, CWA214200H, CWA214201H, CWA214203H, CWA214205H, CWA214208H, CWA214210H, CWA214211H, CWA214212H, CWA214213H, CWA217480H, CWA217481H, CWA217482H, CWA217483H, CWA217484H, CWA217485H, CWA220397H, CWA220400H, CWA220407H, CWA220408H, CWA222904H, CWA224042H, CWA226903H, CWA226919H, CWA230608H, CWA230609H, CWA230611H, CWA230612H, CWA217020H, CWA220851H, CWA224216H, CWA226111H, CWA230832H, CWA231351H, CWA220280H, CWA222986H, CWA223614H, CWA229484H, CWA218262H, CWA224443H, CWA212537H, CWA213744H, CWA214146H, CWA214362H, CWA215549H, CWA215657H, CWA216424H, CWA216460H, CWA216476H, CWA217621H, CWA217808H, CWA217987H, CWA218225H, CWA218288H, CWA219444H, CWA219446H, CWA219708H, CWA221001H, CWA222259H, CWA222260H, CWA222261H, CWA222264H, CWA2…
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-1711-2023 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.