ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1816-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; 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 DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1816-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1816-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1816-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1816-2023
      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 00763000001605, Lot Serial Numbers: CWP603713S, CWP601986S, CWP600810S, CWP602954S, CWP602169S, CWP602564S, CWP602486S, CWP601838S, CWP600696S, CWP602627S, CWP602315S, CWP602621S, CWP604004S, CWP603407S, CWP603894S, CWP604066S, CWP602233S, CWP603772S, CWP603201S, CWP603888S, CWP602797S, CWP603582S, CWP603254S, CWP603475S, CWP602907S, CWP603605S, CWP603606S, CWP602148S, CWP602999S, CWP601940S, CWP602860S, CWP600692S, CWP600693S, CWP601684S, CWP601750S, CWP602026S, CWP602250S, CWP602395S, CWP600661S, CWP600672S, CWP600673S, CWP601025S, CWP601261S, CWP601303S, CWP601404S, CWP601545S, CWP601730S, CWP601740S, CWP601753S, CWP601912S, CWP602158S, CWP602213S, CWP602504S, CWP602670S, CWP603190S, CWP603321S, CWP603588S, CWP601814S, CWP603269S, CWP600319S, CWP600528S, CWP600165S, CWP600198S, CWP600259S, CWP600347S, CWP600382S, CWP600924S, CWP601414S, CWP601449S, CWP601852S, CWP602821S, CWP602897S, CWP602949S, CWP602991S, CWP604050S, CWP601592S, CWP600897S, CWP602865S, CWP600265S, CWP600261S, CWP602153S, CWP600326S, CWP600355S, CWP600697S, CWP600738S, CWP602332S, CWP603593S, CWP600566S, CWP601527S, CWP601561S, CWP600205S, CWP601559S, CWP602115S, CWP600948S, CWP602089S, CWP602090S, CWP602259S, CWP600701S, CWP600954S, CWP601021S, CWP601092S, CWP601271S, CWP601606S, CWP601830S, CWP601886S, CWP601975S, CWP602092S, CWP602349S, CWP603000S, CWP603182S, CWP603241S, CWP603359S, CWP600131S, CWP600634S, CWP600863S, CWP600946S, CWP602578S, CWP603255S, CWP600285S, CWP601037S, CWP601530S, CWP601637S, CWP601716S, CWP602066S, CWP602175S, CWP600749S, CWP600678S, CWP601520S, CWP601522S, CWP601568S, CWP601788S, CWP601840S, CWP602174S, CWP602424S, CWP602550S, CWP602803S, CWP601965S, CWP602135S, CWP600306S, CWP600403S, CWP600632S, CWP600642S, CWP601719S, CWP601733S, CWP601896S, CWP602659S, CWP602785S, CWP600365S, CWP600366S, CWP600406S, CWP600864S, CWP601061S, CWP601099S, CWP601208S, CWP601250S, CWP601251S, CWP601562S, CWP601582S, CWP601598S, CWP601601S, CWP601619S, CWP602473S, CWP603345S, CWP…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1816-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1816-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; 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 00763000001605, Lot Serial Numbers: CWP603713S, CWP601986S, CWP600810S, CWP602954S, CWP602169S, CWP602564S, CWP602486S, CWP601838S, CWP600696S, CWP602627S, CWP602315S, CWP602621S, CWP604004S, CWP603407S, CWP603894S, CWP604066S, CWP602233S, CWP603772S, CWP603201S, CWP603888S, CWP602797S, CWP603582S, CWP603254S, CWP603475S, CWP602907S, CWP603605S, CWP603606S, CWP602148S, CWP602999S, CWP601940S, CWP602860S, CWP600692S, CWP600693S, CWP601684S, CWP601750S, CWP602026S, CWP602250S, CWP602395S, CWP600661S, CWP600672S, CWP600673S, CWP601025S, CWP601261S, CWP601303S, CWP601404S, CWP601545S, CWP601730S, CWP601740S, CWP601753S, CWP601912S, CWP602158S, CWP602213S, CWP602504S, CWP602670S, CWP603190S, CWP603321S, CWP603588S, CWP601814S, CWP603269S, CWP600319S, CWP600528S, CWP600165S, CWP600198S, CWP600259S, CWP600347S, CWP600382S, CWP600924S, CWP601414S, CWP601449S, CWP601852S, CWP602821S, CWP602897S, CWP602949S, CWP602991S, CWP604050S, CWP601592S, CWP600897S, CWP602865S, CWP600265S, CWP600261S, CWP602153S, CWP600326S, CWP600355S, CWP600697S, CWP600738S, CWP602332S, CWP603593S, CWP600566S, CWP601527S, CWP601561S, CWP600205S, CWP601559S, CWP602115S, CWP600948S, CWP602089S, CWP602090S, CWP602259S, CWP600701S, CWP600954S, CWP601021S, CWP601092S, CWP601271S, CWP601606S, CWP601830S, CWP601886S, CWP601975S, CWP602092S, CWP602349S, CWP603000S, 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-1816-2023 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.