ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1814-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; 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 DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1814-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1814-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1814-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1814-2023
      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 00763000001520, Lot Serial Numbers: CWK604305S, CWK601554S, CWK601693S, CWK601762S, CWK603310S, CWK600674S, CWK605298S, CWK605119S, CWK605216S, CWK605052S, CWK605244S, CWK605024S, CWK605176S, CWK605108S, CWK605326S, CWK605015S, CWK605215S, CWK605100S, CWK605123S, CWK604958S, CWK605229S, CWK605502S, CWK604624S, CWK604625S, CWK604396S, CWK605478S, CWK604413S, CWK604933S, CWK605391S, CWK601948S, CWK601949S, CWK601950S, CWK601953S, CWK601961S, CWK601965S, CWK601966S, CWK601970S, CWK601971S, CWK601972S, CWK601974S, CWK601976S, CWK602568S, CWK602617S, CWK602627S, CWK602632S, CWK602691S, CWK602827S, CWK602843S, CWK602870S, CWK601348S, CWK603369S, CWK604247S, CWK604852S, CWK603773S, CWK601726S, CWK601802S, CWK602031S, CWK602325S, CWK602330S, CWK602332S, CWK602336S, CWK602338S, CWK602339S, CWK602355S, CWK602357S, CWK602577S, CWK602645S, CWK602652S, CWK603257S, CWK603258S, CWK603319S, CWK603334S, CWK603926S, CWK603957S, CWK603969S, CWK604118S, CWK604120S, CWK604127S, CWK604307S, CWK604310S, CWK604313S, CWK604321S, CWK605197S, CWK605198S, CWK605207S, CWK605208S, CWK605209S, CWK605210S, CWK605211S, CWK605212S, CWK605449S, CWK605470S, CWK605473S, CWK603235S, CWK603237S, CWK603242S, CWK601913S, CWK602871S, CWK603546S, CWK604544S, CWK604577S, CWK604848S, CWK602774S, CWK603194S, CWK604685S, CWK602551S, CWK604090S, CWK603535S, CWK603951S, CWK601375S, CWK602172S, CWK602462S, CWK602548S, CWK602639S, CWK602643S, CWK602649S, CWK602858S, CWK603058S, CWK603090S, CWK603249S, CWK603289S, CWK603291S, CWK603389S, CWK603437S, CWK603473S, CWK603557S, CWK603727S, CWK603796S, CWK603812S, CWK603923S, CWK603958S, CWK603982S, CWK604107S, CWK604344S, CWK604446S, CWK604543S, CWK604684S, CWK604693S, CWK604845S, CWK604869S, CWK604900S, CWK605126S, CWK605257S, CWK605302S, CWK605396S, CWK605403S, CWK601041S, CWK604110S, CWK602795S, CWK603823S, CWK600763S, CWK601523S, CWK601614S, CWK602461S, CWK602467S, CWK602484S, CWK602723S, CWK603728S, CWK603017S, CWK604545S, CWK600791S, CWK604373S, CWK604362S, CWK…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1814-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1814-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; 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 00763000001520, Lot Serial Numbers: CWK604305S, CWK601554S, CWK601693S, CWK601762S, CWK603310S, CWK600674S, CWK605298S, CWK605119S, CWK605216S, CWK605052S, CWK605244S, CWK605024S, CWK605176S, CWK605108S, CWK605326S, CWK605015S, CWK605215S, CWK605100S, CWK605123S, CWK604958S, CWK605229S, CWK605502S, CWK604624S, CWK604625S, CWK604396S, CWK605478S, CWK604413S, CWK604933S, CWK605391S, CWK601948S, CWK601949S, CWK601950S, CWK601953S, CWK601961S, CWK601965S, CWK601966S, CWK601970S, CWK601971S, CWK601972S, CWK601974S, CWK601976S, CWK602568S, CWK602617S, CWK602627S, CWK602632S, CWK602691S, CWK602827S, CWK602843S, CWK602870S, CWK601348S, CWK603369S, CWK604247S, CWK604852S, CWK603773S, CWK601726S, CWK601802S, CWK602031S, CWK602325S, CWK602330S, CWK602332S, CWK602336S, CWK602338S, CWK602339S, CWK602355S, CWK602357S, CWK602577S, CWK602645S, CWK602652S, CWK603257S, CWK603258S, CWK603319S, CWK603334S, CWK603926S, CWK603957S, CWK603969S, CWK604118S, CWK604120S, CWK604127S, CWK604307S, CWK604310S, CWK604313S, CWK604321S, CWK605197S, CWK605198S, CWK605207S, CWK605208S, CWK605209S, CWK605210S, CWK605211S, CWK605212S, CWK605449S, CWK605470S, CWK605473S, CWK603235S, CWK603237S, CWK603242S, CWK601913S, CWK602871S, CWK603546S, CWK604544S, CWK604577S, CWK604848S, CWK602774S, CWK603194S, CWK604685S, CWK602551S, CWK604090S, CWK603535S, CWK603951S, 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-1814-2023 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.