ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1815-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; 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-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1815-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1815-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1815-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1815-2023
      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 00763000001544, Lot Serial Numbers: CWL609971S, CWL607669S, CWL607665S, CWL601100S, CWL608311S, CWL608330S, CWL606893S, CWL611845S, CWL613316S, CWL613041S, CWL613322S, CWL613037S, CWL612708S, CWL610673S, CWL613504S, CWL613431S, CWL610444S, CWL611258S, CWL612781S, CWL611134S, CWL612934S, CWL610677S, CWL610760S, CWL611725S, CWL612705S, CWL612392S, CWL612791S, CWL613155S, CWL608262S, CWL613137S, CWL613177S, CWL613296S, CWL613214S, CWL613134S, CWL610869S, CWL612023S, CWL605532S, CWL604332S, CWL604336S, CWL604346S, CWL604350S, CWL604352S, CWL604353S, CWL604357S, CWL604361S, CWL604363S, CWL604365S, CWL604367S, CWL604368S, CWL605564S, CWL605583S, CWL605779S, CWL607583S, CWL607825S, CWL608913S, CWL608914S, CWL608966S, CWL609174S, CWL601407S, CWL602224S, CWL604372S, CWL604374S, CWL607414S, CWL607688S, CWL609146S, CWL609294S, CWL610670S, CWL604082S, CWL604249S, CWL604273S, CWL604611S, CWL605101S, CWL605102S, CWL605103S, CWL605105S, CWL605106S, CWL605233S, CWL605235S, CWL605632S, CWL605645S, CWL605652S, CWL606263S, CWL606411S, CWL606795S, CWL607038S, CWL607089S, CWL607337S, CWL607340S, CWL607415S, CWL607803S, CWL608025S, CWL608038S, CWL608141S, CWL608274S, CWL609467S, CWL609469S, CWL609499S, CWL609898S, CWL609902S, CWL609905S, CWL609912S, CWL609921S, CWL610114S, CWL610121S, CWL610633S, CWL611480S, CWL611482S, CWL611483S, CWL611484S, CWL611485S, CWL611487S, CWL611488S, CWL611493S, CWL612304S, CWL612305S, CWL612306S, CWL612307S, CWL612308S, CWL612309S, CWL613023S, CWL613025S, CWL613026S, CWL613029S, CWL613030S, CWL613031S, CWL613032S, CWL613033S, CWL613514S, CWL613515S, CWL613516S, CWL613517S, CWL613518S, CWL606993S, CWL607000S, CWL607006S, CWL607023S, CWL607029S, CWL608573S, CWL608598S, CWL608630S, CWL608638S, CWL609423S, CWL609553S, CWL609947S, CWL605186S, CWL605224S, CWL606331S, CWL608520S, CWL609744S, CWL610410S, CWL611144S, CWL611652S, CWL611862S, CWL611863S, CWL613434S, CWL605994S, CWL610858S, CWL611656S, CWL612207S, CWL612912S, CWL613448S, CWL604483S, CWL604652S, CWL…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1815-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1815-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; 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 00763000001544, Lot Serial Numbers: CWL609971S, CWL607669S, CWL607665S, CWL601100S, CWL608311S, CWL608330S, CWL606893S, CWL611845S, CWL613316S, CWL613041S, CWL613322S, CWL613037S, CWL612708S, CWL610673S, CWL613504S, CWL613431S, CWL610444S, CWL611258S, CWL612781S, CWL611134S, CWL612934S, CWL610677S, CWL610760S, CWL611725S, CWL612705S, CWL612392S, CWL612791S, CWL613155S, CWL608262S, CWL613137S, CWL613177S, CWL613296S, CWL613214S, CWL613134S, CWL610869S, CWL612023S, CWL605532S, CWL604332S, CWL604336S, CWL604346S, CWL604350S, CWL604352S, CWL604353S, CWL604357S, CWL604361S, CWL604363S, CWL604365S, CWL604367S, CWL604368S, CWL605564S, CWL605583S, CWL605779S, CWL607583S, CWL607825S, CWL608913S, CWL608914S, CWL608966S, CWL609174S, CWL601407S, CWL602224S, CWL604372S, CWL604374S, CWL607414S, CWL607688S, CWL609146S, CWL609294S, CWL610670S, CWL604082S, CWL604249S, CWL604273S, CWL604611S, CWL605101S, CWL605102S, CWL605103S, CWL605105S, CWL605106S, CWL605233S, CWL605235S, CWL605632S, CWL605645S, CWL605652S, CWL606263S, CWL606411S, CWL606795S, CWL607038S, CWL607089S, CWL607337S, CWL607340S, CWL607415S, CWL607803S, CWL608025S, CWL608038S, CWL608141S, CWL608274S, CWL609467S, CWL609469S, CWL609499S, CWL609898S, CWL609902S, CWL609905S, CWL609912S, CWL609921S, CWL610114S, CWL610121S, CWL610633S, CWL611480S, CWL611482S, CWL611483S, CWL611484S, CW…
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-1815-2023 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.