ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1819-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; 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 XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1819-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1819-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1819-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1819-2023
      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 00763000178468. Lot Serial numbers: RSD605765S, RSD605767S, RSD607880S, RSD607881S, RSD607886S, RSD607890S, RSD603551S, RSD603552S, RSD603553S, RSD603554S, RSD603555S, RSD600536S, RSD601541S, RSD602283S, RSD602524S, RSD602542S, RSD602924S, RSD603303S, RSD603396S, RSD607136S, RSD608177S, RSD608547S, RSD606272S, RSD607000S, RSD607711S, RSD607712S, RSD602036S, RSD602645S, RSD602659S, RSD603096S, RSD603670S, RSD604815S, RSD608193S, RSD605918S, RSD605919S, RSD605920S, RSD605921S, RSD605922S, RSD605923S, RSD605924S, RSD605926S, RSD605927S, RSD605929S, RSD605930S, RSD605931S, RSD605932S, RSD605933S, RSD604238S, RSD604294S, RSD604312S, RSD604313S, RSD604314S, RSD604614S, RSD604616S, RSD604710S, RSD604721S, RSD604725S, RSD605925S, RSD607788S, RSD607789S, RSD607790S, RSD607791S, RSD607792S, RSD607793S, RSD607794S, RSD607795S, RSD607797S, RSD607800S, RSD607801S, RSD607802S, RSD609083S, RSD609084S, RSD609085S, RSD605068S, RSD608525S, RSD609065S, RSD609066S, RSD609067S, RSD609069S, RSD609071S, RSD609072S, RSD609073S, RSD609075S, RSD609079S, RSD609080S, RSD609081S, RSD609082S, RSD601603S, RSD601960S, RSD602778S, RSD603181S, RSD603321S, RSD603672S, RSD603879S, RSD606554S, RSD608293S, RSD600145S, RSD601926S, RSD602728S, RSD603152S, RSD604065S, RSD607875S, RSD603750S, RSD606677S, RSD600100S, RSD600200S, RSD601455S, RSD601551S, RSD601552S, RSD601750S, RSD602233S, RSD608150S, RSD609043S, RSD608404S, RSD608422S, RSD609843S, RSD609845S, RSD609846S, RSD603825S, RSD603826S, RSD609842S, RSD610592S, RSD610593S, RSD608739S, RSD608718S, RSD606638S, RSD606653S, RSD608253S, RSD601449S, RSD601450S, RSD603168S, RSD610535S, RSD600188S, RSD605289S, RSD605802S, RSD606161S, RSD608659S, RSD608720S, RSD603329S, RSD604030S, RSD605997S, RSD605998S, RSD608060S, RSD605348S, RSD605787S, RSD605790S, RSD606704S, RSD608634S, RSD608795S, RSD608855S, RSD609276S, RSD609277S, RSD609278S, RSD600209S, RSD600214S, RSD600366S, RSD600475S, RSD600484S, RSD600485S, RSD600499S, RSD600513S, RSD600525S, RSD600531S, RSD…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1819-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1819-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; 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 00763000178468. Lot Serial numbers: RSD605765S, RSD605767S, RSD607880S, RSD607881S, RSD607886S, RSD607890S, RSD603551S, RSD603552S, RSD603553S, RSD603554S, RSD603555S, RSD600536S, RSD601541S, RSD602283S, RSD602524S, RSD602542S, RSD602924S, RSD603303S, RSD603396S, RSD607136S, RSD608177S, RSD608547S, RSD606272S, RSD607000S, RSD607711S, RSD607712S, RSD602036S, RSD602645S, RSD602659S, RSD603096S, RSD603670S, RSD604815S, RSD608193S, RSD605918S, RSD605919S, RSD605920S, RSD605921S, RSD605922S, RSD605923S, RSD605924S, RSD605926S, RSD605927S, RSD605929S, RSD605930S, RSD605931S, RSD605932S, RSD605933S, RSD604238S, RSD604294S, RSD604312S, RSD604313S, RSD604314S, RSD604614S, RSD604616S, RSD604710S, RSD604721S, RSD604725S, RSD605925S, RSD607788S, RSD607789S, RSD607790S, RSD607791S, RSD607792S, RSD607793S, RSD607794S, RSD607795S, RSD607797S, RSD607800S, RSD607801S, RSD607802S, RSD609083S, RSD609084S, RSD609085S, RSD605068S, RSD608525S, RSD609065S, RSD609066S, RSD609067S, RSD609069S, RSD609071S, RSD609072S, RSD609073S, RSD609075S, RSD609079S, RSD609080S, RSD609081S, RSD609082S, RSD601603S, RSD601960S, RSD602778S, RSD603181S, RSD603321S, RSD603672S, RSD603879S, RSD606554S, RSD608293S, RSD600145S, RSD601926S, RSD602728S, RSD603152S, RSD604065S, RSD607875S, RSD603750S, RSD606677S, RSD600100S, RSD600200S, RSD601455S, RSD601551S, RSD601552S, RS…
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-1819-2023 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.