ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1712-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; 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 DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1712-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1712-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1712-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1712-2023
      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 00643169720497, Lot Serial Numbers: PFZ236436H, PFZ242339H, PFZ247708H, PFZ247891H, PFZ250783H, PFZ252117H, PFZ259560H, PFZ265053H, PFZ271895H, PFZ248688H, PFZ254957H, PFZ260373H, PFZ273832H, PFZ244136H, PFZ245315H, PFZ264212H, PFZ271087H, PFZ273388H, PFZ238454H, PFZ242886H, PFZ245032H, PFZ245482H, PFZ251539H, PFZ251620H, PFZ254361H, PFZ256071H, PFZ258481H, PFZ259582H, PFZ261497H, PFZ263430H, PFZ264999H, PFZ268418H, PFZ269828H, PFZ274151H, PFZ236422H, PFZ239293H, PFZ240140H, PFZ242722H, PFZ244519H, PFZ244850H, PFZ246467H, PFZ247093H, PFZ248638H, PFZ250072H, PFZ250429H, PFZ251666H, PFZ263854H, PFZ268573H, PFZ268973H, PFZ240263H, PFZ242174H, PFZ247965H, PFZ263650H, PFZ268685H, PFZ270530H, PFZ240280H, PFZ240282H, PFZ240283H, PFZ240284H, PFZ240285H, PFZ240286H, PFZ240287H, PFZ240288H, PFZ240292H, PFZ240294H, PFZ240295H, PFZ240296H, PFZ245429H, PFZ245430H, PFZ245435H, PFZ245437H, PFZ253305H, PFZ253306H, PFZ253312H, PFZ253315H, PFZ253317H, PFZ253318H, PFZ256364H, PFZ256365H, PFZ256366H, PFZ256367H, PFZ256368H, PFZ256371H, PFZ257391H, PFZ261794H, PFZ270374H, PFZ271142H, PFZ271143H, PFZ236326H, PFZ236764H, PFZ237716H, PFZ238433H, PFZ243679H, PFZ244764H, PFZ246310H, PFZ246566H, PFZ246737H, PFZ247439H, PFZ249902H, PFZ249948H, PFZ261645H, PFZ263628H, PFZ263982H, PFZ264671H, PFZ266539H, PFZ273368H, PFZ274260H, PFZ242175H, PFZ243885H, PFZ243969H, PFZ243986H, PFZ244929H, PFZ251483H, PFZ256616H, PFZ260183H, PFZ260192H, PFZ261455H, PFZ266251H, PFZ273240H, PFZ274766H, PFZ269396H, PFZ271560H, PFZ274773H, PFZ236231H, PFZ237619H, PFZ237945H, PFZ238006H, PFZ238412H, PFZ239804H, PFZ240431H, PFZ240466H, PFZ241697H, PFZ244314H, PFZ245164H, PFZ245800H, PFZ246090H, PFZ246094H, PFZ246236H, PFZ247740H, PFZ247933H, PFZ248109H, PFZ248283H, PFZ248339H, PFZ248508H, PFZ248626H, PFZ250107H, PFZ250741H, PFZ252021H, PFZ252022H, PFZ252024H, PFZ252025H, PFZ252026H, PFZ252039H, PFZ252071H, PFZ253127H, PFZ256234H, PFZ257883H, PFZ257885H, PFZ257888H, PFZ258670H, PFZ258724H, PFZ259092H, PFZ259128H, PFZ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1712-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1712-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; 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 00643169720497, Lot Serial Numbers: PFZ236436H, PFZ242339H, PFZ247708H, PFZ247891H, PFZ250783H, PFZ252117H, PFZ259560H, PFZ265053H, PFZ271895H, PFZ248688H, PFZ254957H, PFZ260373H, PFZ273832H, PFZ244136H, PFZ245315H, PFZ264212H, PFZ271087H, PFZ273388H, PFZ238454H, PFZ242886H, PFZ245032H, PFZ245482H, PFZ251539H, PFZ251620H, PFZ254361H, PFZ256071H, PFZ258481H, PFZ259582H, PFZ261497H, PFZ263430H, PFZ264999H, PFZ268418H, PFZ269828H, PFZ274151H, PFZ236422H, PFZ239293H, PFZ240140H, PFZ242722H, PFZ244519H, PFZ244850H, PFZ246467H, PFZ247093H, PFZ248638H, PFZ250072H, PFZ250429H, PFZ251666H, PFZ263854H, PFZ268573H, PFZ268973H, PFZ240263H, PFZ242174H, PFZ247965H, PFZ263650H, PFZ268685H, PFZ270530H, PFZ240280H, PFZ240282H, PFZ240283H, PFZ240284H, PFZ240285H, PFZ240286H, PFZ240287H, PFZ240288H, PFZ240292H, PFZ240294H, PFZ240295H, PFZ240296H, PFZ245429H, PFZ245430H, PFZ245435H, PFZ245437H, PFZ253305H, PFZ253306H, PFZ253312H, PFZ253315H, PFZ253317H, PFZ253318H, PFZ256364H, PFZ256365H, PFZ256366H, PFZ256367H, PFZ256368H, PFZ256371H, PFZ257391H, PFZ261794H, PFZ270374H, PFZ271142H, PFZ271143H, PFZ236326H, PFZ236764H, PFZ237716H, PFZ238433H, PFZ243679H, PFZ244764H, PFZ246310H, PFZ246566H, PFZ246737H, PFZ247439H, PFZ249902H, PFZ249948H, PFZ261645H, PFZ263628H, PFZ263982H, PFZ264671H, PFZ266539H, PFZ273368H, PFZ274260H, PFZ242175H,…
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-1712-2023 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.