ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1810-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; 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 DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1810-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1810-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1810-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1810-2023
      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 00643169837768, Lot Serial Numbers: CWE602084S, CWE601758S, CWE600712S, CWE602003S, CWE600626S, CWE600766S, CWE601482S, CWE601602S, CWE602520S, CWE602570S, CWE602622S, CWE601590S, CWE602288S, CWE601918S, CWE602150S, CWE602184S, CWE602565S, CWE602589S, CWE600926S, CWE600588S, CWE601390S, CWE601395S, CWE601481S, CWE601541S, CWE601612S, CWE601749S, CWE601831S, CWE601843S, CWE602038S, CWE600874S, CWE601632S, CWE601996S, CWE602041S, CWE601792S, CWE602396S, CWE600375S, CWE601990S, CWE600553S, CWE601369S, CWE601392S, CWE601766S, CWE601769S, CWE601695S, CWE601401S, CWE601470S, CWE602016S, CWE602094S, CWE602195S, CWE602495S, CWE600746S, CWE601256S, CWE600733S, CWE601348S, CWE601487S, CWE601524S, CWE600350S, CWE600974S, CWE601438S, CWE601700S, CWE601989S, CWE602012S, CWE602376S, CWE600461S, CWE600373S, CWE600530S, CWE601325S, CWE601582S, CWE601644S, CWE601701S, CWE601995S, CWE601282S, CWE601850S, CWE601890S, CWE600526S, CWE602605S, CWE600525S, CWE600372S, CWE600396S, CWE601006S, CWE601277S, CWE601694S, CWE601596S, CWE601652S, CWE601992S, CWE602044S, CWE601462S, CWE601538S, CWE600725S, CWE600729S, CWE601579S, CWE602053S, CWE601643S, CWE602123S, CWE601993S, CWE600935S, CWE600936S, CWE601442S, CWE601444S, CWE601533S, CWE602080S, CWE602135S, CWE600502S, CWE600735S, CWE600864S, CWE601922S, CWE601927S, CWE602035S, CWE602078S, CWE602118S, CWE602122S, CWE602156S, CWE602169S, CWE602232S, CWE602241S, CWE602380S, CWE602423S, CWE602426S, CWE602508S, CWE602539S, CWE602554S, CWE602379S, CWE600880S, CWE601105S, CWE601539S, CWE601835S, CWE601387S, CWE602190S, CWE600349S, CWE600760S, CWE602574S, CWE602591S, CWE600395S, CWE600405S, CWE600407S, CWE600442S, CWE600584S, CWE600650S, CWE601108S, CWE601263S, CWE601313S, CWE601645S, CWE600523S, CWE600679S, CWE601008S, CWE601086S, CWE601146S, CWE601266S, CWE601393S, CWE601396S, CWE601466S, CWE601542S, CWE602039S, CWE602397S, CWE600504S, CWE600575S, CWE600681S, CWE601095S, CWE601101S, CWE601398S, CWE601526S, CWE601724S, CWE601834S, CWE602052S, CWE…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1810-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1810-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; 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 00643169837768, Lot Serial Numbers: CWE602084S, CWE601758S, CWE600712S, CWE602003S, CWE600626S, CWE600766S, CWE601482S, CWE601602S, CWE602520S, CWE602570S, CWE602622S, CWE601590S, CWE602288S, CWE601918S, CWE602150S, CWE602184S, CWE602565S, CWE602589S, CWE600926S, CWE600588S, CWE601390S, CWE601395S, CWE601481S, CWE601541S, CWE601612S, CWE601749S, CWE601831S, CWE601843S, CWE602038S, CWE600874S, CWE601632S, CWE601996S, CWE602041S, CWE601792S, CWE602396S, CWE600375S, CWE601990S, CWE600553S, CWE601369S, CWE601392S, CWE601766S, CWE601769S, CWE601695S, CWE601401S, CWE601470S, CWE602016S, CWE602094S, CWE602195S, CWE602495S, CWE600746S, CWE601256S, CWE600733S, CWE601348S, CWE601487S, CWE601524S, CWE600350S, CWE600974S, CWE601438S, CWE601700S, CWE601989S, CWE602012S, CWE602376S, CWE600461S, CWE600373S, CWE600530S, CWE601325S, CWE601582S, CWE601644S, CWE601701S, CWE601995S, CWE601282S, CWE601850S, CWE601890S, CWE600526S, CWE602605S, CWE600525S, CWE600372S, CWE600396S, CWE601006S, CWE601277S, CWE601694S, CWE601596S, CWE601652S, CWE601992S, CWE602044S, CWE601462S, CWE601538S, CWE600725S, CWE600729S, CWE601579S, CWE602053S, CWE601643S, CWE602123S, CWE601993S, CWE600935S, CWE600936S, CWE601442S, CWE601444S, CWE601533S, CWE602080S, CWE602135S, CWE600502S, CWE600735S, CWE600864S, CWE601922S, CWE601927S, CWE602035S, CWE602078S, CWE…
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-1810-2023 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.