ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1718-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; 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-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1718-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1718-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1718-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1718-2023
      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 00763000001506, Lot Serial Numbers: CWN606940S, CWN606941S, CWN606806S, CWN609866S, CWN607173S, CWN607174S, CWN606850S, CWN605016S, CWN605224S, CWN605226S, CWN602473S, CWN605696S, CWN606066S, CWN601517S, CWN610794S, CWN611698S, CWN611709S, CWN611042S, CWN611699S, CWN608530S, CWN611057S, CWN611194S, CWN611137S, CWN611173S, CWN611168S, CWN610989S, CWN610994S, CWN610999S, CWN608676S, CWN610063S, CWN608932S, CWN609322S, CWN610602S, CWN608143S, CWN610351S, CWN611528S, CWN611651S, CWN607995S, CWN611583S, CWN608694S, CWN611439S, CWN611468S, CWN611541S, CWN611395S, CWN608844S, CWN611563S, CWN611417S, CWN608827S, CWN608184S, CWN608185S, CWN607983S, CWN609341S, CWN612034S, CWN610308S, CWN609462S, CWN608691S, CWN611586S, CWN611558S, CWN611650S, CWN611477S, CWN611385S, CWN611576S, CWN608837S, CWN608405S, CWN610408S, CWN611574S, CWN611547S, CWN611599S, CWN611554S, CWN603401S, CWN603403S, CWN603404S, CWN603405S, CWN603407S, CWN603408S, CWN603409S, CWN603516S, CWN603517S, CWN603518S, CWN603521S, CWN603779S, CWN603780S, CWN603785S, CWN603786S, CWN603944S, CWN603945S, CWN603955S, CWN603965S, CWN604184S, CWN604203S, CWN604223S, CWN604232S, CWN605362S, CWN605449S, CWN605556S, CWN605559S, CWN605561S, CWN605562S, CWN605577S, CWN605624S, CWN605640S, CWN605642S, CWN605644S, CWN605645S, CWN605650S, CWN605651S, CWN605655S, CWN605677S, CWN605678S, CWN606462S, CWN606463S, CWN606464S, CWN606712S, CWN606713S, CWN606727S, CWN606731S, CWN606732S, CWN606773S, CWN601994S, CWN602772S, CWN603379S, CWN605032S, CWN606242S, CWN606359S, CWN607834S, CWN607835S, CWN607836S, CWN608620S, CWN608621S, CWN608622S, CWN608623S, CWN608624S, CWN608625S, CWN608626S, CWN608628S, CWN608629S, CWN609636S, CWN609637S, CWN609638S, CWN609639S, CWN609640S, CWN609641S, CWN609642S, CWN607664S, CWN608090S, CWN611266S, CWN611279S, CWN611280S, CWN611281S, CWN611282S, CWN611283S, CWN611284S, CWN603096S, CWN603173S, CWN603182S, CWN603316S, CWN603317S, CWN603384S, CWN603385S, CWN603386S, CWN603457S, CWN603473S, CWN603475S, CWN…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1718-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1718-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; 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 00763000001506, Lot Serial Numbers: CWN606940S, CWN606941S, CWN606806S, CWN609866S, CWN607173S, CWN607174S, CWN606850S, CWN605016S, CWN605224S, CWN605226S, CWN602473S, CWN605696S, CWN606066S, CWN601517S, CWN610794S, CWN611698S, CWN611709S, CWN611042S, CWN611699S, CWN608530S, CWN611057S, CWN611194S, CWN611137S, CWN611173S, CWN611168S, CWN610989S, CWN610994S, CWN610999S, CWN608676S, CWN610063S, CWN608932S, CWN609322S, CWN610602S, CWN608143S, CWN610351S, CWN611528S, CWN611651S, CWN607995S, CWN611583S, CWN608694S, CWN611439S, CWN611468S, CWN611541S, CWN611395S, CWN608844S, CWN611563S, CWN611417S, CWN608827S, CWN608184S, CWN608185S, CWN607983S, CWN609341S, CWN612034S, CWN610308S, CWN609462S, CWN608691S, CWN611586S, CWN611558S, CWN611650S, CWN611477S, CWN611385S, CWN611576S, CWN608837S, CWN608405S, CWN610408S, CWN611574S, CWN611547S, CWN611599S, CWN611554S, CWN603401S, CWN603403S, CWN603404S, CWN603405S, CWN603407S, CWN603408S, CWN603409S, CWN603516S, CWN603517S, CWN603518S, CWN603521S, CWN603779S, CWN603780S, CWN603785S, CWN603786S, CWN603944S, CWN603945S, CWN603955S, CWN603965S, CWN604184S, CWN604203S, CWN604223S, CWN604232S, CWN605362S, CWN605449S, CWN605556S, CWN605559S, CWN605561S, CWN605562S, CWN605577S, CWN605624S, CWN605640S, CWN605642S, CWN605644S, CWN605645S, CWN605650S, CWN605651S, CWN605655S, CWN605677S, CWN605678S, 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-1718-2023 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.