ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1717-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; 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 DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1717-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1717-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1717-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1717-2023
      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 00763000001483, Lot Serial Numbers: CWM603134S, CWM600439S, CWM601269S, CWM603840S, CWM603922S, CWM601037S, CWM602990S, CWM603292S, CWM602888S, CWM602567S, CWM604350S, CWM604400S, CWM604147S, CWM604447S, CWM603919S, CWM604293S, CWM603993S, CWM604453S, CWM604276S, CWM603779S, CWM603512S, CWM604434S, CWM604110S, CWM603974S, CWM604303S, CWM604451S, CWM604296S, CWM603643S, CWM604349S, CWM603935S, CWM603697S, CWM603897S, CWM604404S, CWM603551S, CWM601796S, CWM601798S, CWM601800S, CWM601801S, CWM601802S, CWM601905S, CWM601911S, CWM601931S, CWM602000S, CWM602003S, CWM602004S, CWM602005S, CWM602006S, CWM602097S, CWM602098S, CWM602124S, CWM602139S, CWM602709S, CWM602710S, CWM602711S, CWM602823S, CWM602836S, CWM602838S, CWM602847S, CWM602848S, CWM602883S, CWM602898S, CWM603276S, CWM600958S, CWM601164S, CWM601353S, CWM601410S, CWM601640S, CWM601831S, CWM602141S, CWM603581S, CWM603582S, CWM603627S, CWM603628S, CWM604291S, CWM604292S, CWM601211S, CWM601263S, CWM601339S, CWM601506S, CWM601641S, CWM601775S, CWM601830S, CWM601834S, CWM601838S, CWM601839S, CWM601969S, CWM601974S, CWM601975S, CWM601982S, CWM602156S, CWM602313S, CWM602566S, CWM602573S, CWM602580S, CWM602662S, CWM602663S, CWM602864S, CWM602921S, CWM603097S, CWM603100S, CWM603191S, CWM603193S, CWM603334S, CWM603336S, CWM603361S, CWM603421S, CWM603445S, CWM603446S, CWM603573S, CWM603574S, CWM603714S, CWM603717S, CWM603718S, CWM603719S, CWM603720S, CWM603721S, CWM603722S, CWM603723S, CWM603927S, CWM603928S, CWM603930S, CWM603933S, CWM603934S, CWM603937S, CWM603939S, CWM603940S, CWM604396S, CWM604397S, CWM604398S, CWM603776S, CWM603777S, CWM603799S, CWM603765S, CWM603734S, CWM603795S, CWM603797S, CWM603798S, CWM603775S, CWM602189S, CWM602287S, CWM602291S, CWM602828S, CWM602829S, CWM602833S, CWM602271S, CWM603033S, CWM603689S, CWM601460S, CWM602068S, CWM601398S, CWM601455S, CWM601835S, CWM602588S, CWM603187S, CWM602165S, CWM601754S, CWM602951S, CWM603416S, CWM601079S, CWM601128S, CWM602397S, CWM603979S, CWM601709S, CWM…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1717-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1717-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; 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 00763000001483, Lot Serial Numbers: CWM603134S, CWM600439S, CWM601269S, CWM603840S, CWM603922S, CWM601037S, CWM602990S, CWM603292S, CWM602888S, CWM602567S, CWM604350S, CWM604400S, CWM604147S, CWM604447S, CWM603919S, CWM604293S, CWM603993S, CWM604453S, CWM604276S, CWM603779S, CWM603512S, CWM604434S, CWM604110S, CWM603974S, CWM604303S, CWM604451S, CWM604296S, CWM603643S, CWM604349S, CWM603935S, CWM603697S, CWM603897S, CWM604404S, CWM603551S, CWM601796S, CWM601798S, CWM601800S, CWM601801S, CWM601802S, CWM601905S, CWM601911S, CWM601931S, CWM602000S, CWM602003S, CWM602004S, CWM602005S, CWM602006S, CWM602097S, CWM602098S, CWM602124S, CWM602139S, CWM602709S, CWM602710S, CWM602711S, CWM602823S, CWM602836S, CWM602838S, CWM602847S, CWM602848S, CWM602883S, CWM602898S, CWM603276S, CWM600958S, CWM601164S, CWM601353S, CWM601410S, CWM601640S, CWM601831S, CWM602141S, CWM603581S, CWM603582S, CWM603627S, CWM603628S, CWM604291S, CWM604292S, CWM601211S, CWM601263S, CWM601339S, CWM601506S, CWM601641S, CWM601775S, CWM601830S, CWM601834S, CWM601838S, CWM601839S, CWM601969S, CWM601974S, CWM601975S, CWM601982S, CWM602156S, CWM602313S, CWM602566S, CWM602573S, CWM602580S, CWM602662S, CWM602663S, CWM602864S, CWM602921S, CWM603097S, CWM603100S, CWM603191S, CWM603193S, CWM603334S, CWM603336S, CWM603361S, CWM603421S, CWM603445S, CWM603446S, CWM603573S, 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-1717-2023 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.