ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1723-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; 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 DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1723-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1723-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1723-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1723-2023
      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 00763000178345, Lot Serial Numbers: RSM612933S, RSM612934S, RSM612935S, RSM621211S, RSM604622S, RSM604623S, RSM608882S, RSM621210S, RSM621212S, RSM612673S, RSM609800S, RSM610899S, RSM619550S, RSM620275S, RSM620130S, RSM615997S, RSM619083S, RSM623383S, RSM623721S, RSM610958S, RSM616552S, RSM614351S, RSM618224S, RSM604877S, RSM612655S, RSM612656S, RSM612657S, RSM612659S, RSM621000S, RSM621003S, RSM621005S, RSM608749S, RSM608750S, RSM608751S, RSM608752S, RSM610434S, RSM610435S, RSM620999S, RSM621001S, RSM621004S, RSM617554S, RSM617555S, RSM617556S, RSM617558S, RSM617559S, RSM617557S, RSM613882S, RSM614841S, RSM615782S, RSM615936S, RSM616172S, RSM616444S, RSM619209S, RSM619289S, RSM619651S, RSM619896S, RSM620690S, RSM600889S, RSM604260S, RSM605557S, RSM606370S, RSM606396S, RSM607298S, RSM610073S, RSM610769S, RSM612584S, RSM618160S, RSM623166S, RSM600390S, RSM600757S, RSM600770S, RSM600846S, RSM600890S, RSM601127S, RSM601129S, RSM601133S, RSM604873S, RSM605085S, RSM605586S, RSM605863S, RSM605974S, RSM606168S, RSM606211S, RSM606217S, RSM606273S, RSM606468S, RSM607358S, RSM607466S, RSM608015S, RSM608017S, RSM608063S, RSM609483S, RSM609943S, RSM610757S, RSM611542S, RSM612678S, RSM614146S, RSM614433S, RSM619501S, RSM619502S, RSM610670S, RSM616050S, RSM620974S, RSM620975S, RSM620977S, RSM620978S, RSM617600S, RSM620979S, RSM611884S, RSM600128S, RSM600406S, RSM600701S, RSM600702S, RSM600783S, RSM600961S, RSM600965S, RSM600967S, RSM600973S, RSM600979S, RSM601064S, RSM601065S, RSM603558S, RSM604180S, RSM604444S, RSM604446S, RSM604518S, RSM604519S, RSM604524S, RSM604535S, RSM604953S, RSM605787S, RSM606351S, RSM606355S, RSM606356S, RSM606357S, RSM607929S, RSM607932S, RSM607933S, RSM607934S, RSM607938S, RSM608057S, RSM608674S, RSM609805S, RSM616644S, RSM619776S, RSM604397S, RSM611533S, RSM617621S, RSM617622S, RSM619238S, RSM619239S, RSM621513S, RSM621514S, RSM607693S, RSM607696S, RSM608898S, RSM608901S, RSM621512S, RSM622064S, RSM623752S, RSM623753S, RSM619882S, RSM610071S, RSM…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1723-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1723-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; 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 00763000178345, Lot Serial Numbers: RSM612933S, RSM612934S, RSM612935S, RSM621211S, RSM604622S, RSM604623S, RSM608882S, RSM621210S, RSM621212S, RSM612673S, RSM609800S, RSM610899S, RSM619550S, RSM620275S, RSM620130S, RSM615997S, RSM619083S, RSM623383S, RSM623721S, RSM610958S, RSM616552S, RSM614351S, RSM618224S, RSM604877S, RSM612655S, RSM612656S, RSM612657S, RSM612659S, RSM621000S, RSM621003S, RSM621005S, RSM608749S, RSM608750S, RSM608751S, RSM608752S, RSM610434S, RSM610435S, RSM620999S, RSM621001S, RSM621004S, RSM617554S, RSM617555S, RSM617556S, RSM617558S, RSM617559S, RSM617557S, RSM613882S, RSM614841S, RSM615782S, RSM615936S, RSM616172S, RSM616444S, RSM619209S, RSM619289S, RSM619651S, RSM619896S, RSM620690S, RSM600889S, RSM604260S, RSM605557S, RSM606370S, RSM606396S, RSM607298S, RSM610073S, RSM610769S, RSM612584S, RSM618160S, RSM623166S, RSM600390S, RSM600757S, RSM600770S, RSM600846S, RSM600890S, RSM601127S, RSM601129S, RSM601133S, RSM604873S, RSM605085S, RSM605586S, RSM605863S, RSM605974S, RSM606168S, RSM606211S, RSM606217S, RSM606273S, RSM606468S, RSM607358S, RSM607466S, RSM608015S, RSM608017S, RSM608063S, RSM609483S, RSM609943S, RSM610757S, RSM611542S, RSM612678S, RSM614146S, RSM614433S, RSM619501S, RSM619502S, RSM610670S, RSM616050S, RSM620974S, RSM620975S, RSM620977S, RSM620978S, RSM617600S, RSM620979S, RSM611884S…
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-1723-2023 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.