ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1821-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT VR MRI DF4, Model Number DVPB3D4; 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 COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1821-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1821-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1821-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1821-2023
      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 00763000178512, Lot Serial Numbers: RSF600012S, RSF600254S, RSF600591S, RSF600655S, RSF600822S, RSF601247S, RSF602653S, RSF603908S, RSF601102S, RSF607914S, RSF605967S, RSF600633S, RSF600649S, RSF600867S, RSF600868S, RSF600869S, RSF600872S, RSF600873S, RSF600874S, RSF600875S, RSF600876S, RSF600878S, RSF600880S, RSF600883S, RSF602930S, RSF602991S, RSF602998S, RSF603002S, RSF603003S, RSF603013S, RSF603018S, RSF603019S, RSF603022S, RSF603026S, RSF603027S, RSF603030S, RSF603032S, RSF603033S, RSF603034S, RSF603035S, RSF603036S, RSF603736S, RSF603737S, RSF603741S, RSF603742S, RSF603744S, RSF603746S, RSF603747S, RSF603749S, RSF603754S, RSF603755S, RSF603756S, RSF603758S, RSF603759S, RSF603762S, RSF603763S, RSF603764S, RSF603799S, RSF603802S, RSF603804S, RSF603806S, RSF603810S, RSF603813S, RSF603818S, RSF603821S, RSF603824S, RSF602665S, RSF602703S, RSF603249S, RSF603648S, RSF603939S, RSF607644S, RSF601171S, RSF601174S, RSF602584S, RSF602743S, RSF600887S, RSF602678S, RSF608130S, RSF600767S, RSF608097S, RSF604855S, RSF606263S, RSF601206S, RSF601486S, RSF601567S, RSF601571S, RSF600924S, RSF601224S, RSF601226S, RSF602817S, RSF603405S, RSF603521S, RSF603678S, RSF602595S, RSF604129S, RSF600687S, RSF600210S, RSF602849S, RSF607243S, RSF607244S, RSF607291S, RSF604110S, RSF604146S, RSF605150S, RSF607995S, RSF600352S, RSF601546S, RSF607225S, RSF606605S, RSF600269S, RSF600940S, RSF601190S, RSF603550S, RSF604130S, RSF608014S, RSF600303S, RSF602434S, RSF602435S, RSF602449S, RSF602461S, RSF602466S, RSF607173S, RSF607174S, RSF600954S, RSF600955S, RSF602586S, RSF602587S, RSF602597S, RSF602804S, RSF603465S, RSF600982S, RSF603213S, RSF605644S, RSF606195S, RSF601058S, RSF603647S, RSF603724S, RSF604582S, RSF600219S, RSF601397S, RSF601539S, RSF602709S, RSF602757S, RSF603794S, RSF603973S, RSF604054S, RSF600443S, RSF600706S, RSF600721S, RSF600729S, RSF601434S, RSF603726S, RSF606532S, RSF603464S, RSF608114S, RSF601093S, RSF603450S, RSF607337S, RSF607359S, RSF600793S, RSF600805S, RSF600808S, RSF…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1821-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1821-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD COBALT VR MRI DF4, Model Number DVPB3D4; 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 00763000178512, Lot Serial Numbers: RSF600012S, RSF600254S, RSF600591S, RSF600655S, RSF600822S, RSF601247S, RSF602653S, RSF603908S, RSF601102S, RSF607914S, RSF605967S, RSF600633S, RSF600649S, RSF600867S, RSF600868S, RSF600869S, RSF600872S, RSF600873S, RSF600874S, RSF600875S, RSF600876S, RSF600878S, RSF600880S, RSF600883S, RSF602930S, RSF602991S, RSF602998S, RSF603002S, RSF603003S, RSF603013S, RSF603018S, RSF603019S, RSF603022S, RSF603026S, RSF603027S, RSF603030S, RSF603032S, RSF603033S, RSF603034S, RSF603035S, RSF603036S, RSF603736S, RSF603737S, RSF603741S, RSF603742S, RSF603744S, RSF603746S, RSF603747S, RSF603749S, RSF603754S, RSF603755S, RSF603756S, RSF603758S, RSF603759S, RSF603762S, RSF603763S, RSF603764S, RSF603799S, RSF603802S, RSF603804S, RSF603806S, RSF603810S, RSF603813S, RSF603818S, RSF603821S, RSF603824S, RSF602665S, RSF602703S, RSF603249S, RSF603648S, RSF603939S, RSF607644S, RSF601171S, RSF601174S, RSF602584S, RSF602743S, RSF600887S, RSF602678S, RSF608130S, RSF600767S, RSF608097S, RSF604855S, RSF606263S, RSF601206S, RSF601486S, RSF601567S, RSF601571S, RSF600924S, RSF601224S, RSF601226S, RSF602817S, RSF603405S, RSF603521S, RSF603678S, RSF602595S, RSF604129S, RSF600687S, RSF600210S, RSF602849S, RSF607243S, RSF607244S, RSF607291S, RSF604110S, RSF604146S, RSF605150S, RSF607995S, RSF600352S, RSF601546S, RSF607225S, RSF60…
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-1821-2023 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.