ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1721-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; 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 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1721-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1721-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1721-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1721-2023
      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 00763000178338, Lot Serial Numbers: RSL602442S, RSL601336S, RSL600186S, RSL602060S, RSL601499S, RSL601501S, RSL602893S, RSL602901S, RSL602941S, RSL602955S, RSL602420S, RSL602899S, RSL601490S, RSL602690S, RSL600167S, RSL600499S, RSL600561S, RSL600563S, RSL600564S, RSL600565S, RSL601867S, RSL601868S, RSL601870S, RSL601966S, RSL603729S, RSL601838S, RSL602889S, RSL600163S, RSL602444S, RSL602823S, RSL602826S, RSL603092S, RSL603105S, RSL603233S, RSL603237S, RSL603565S, RSL600206S, RSL600230S, RSL600231S, RSL601723S, RSL601789S, RSL601878S, RSL602705S, RSL602854S, RSL602828S, RSL602933S, RSL603236S, RSL601484S, RSL601988S, RSL603618S, RSL602324S, RSL602979S, RSL603759S, RSL600237S, RSL601990S, RSL600172S, RSL602465S, RSL602466S, RSL602467S, RSL602468S, RSL602469S, RSL602470S, RSL602471S, RSL602472S, RSL602892S, RSL603257S, RSL603262S, RSL603263S, RSL603264S, RSL601873S, RSL601874S, RSL601875S, RSL601876S, RSL601887S, RSL601895S, RSL602043S, RSL602044S, RSL602045S, RSL602046S, RSL602047S, RSL602048S, RSL602049S, RSL602050S, RSL602051S, RSL602052S, RSL602053S, RSL602054S, RSL602055S, RSL602056S, RSL602058S, RSL602059S, RSL602221S, RSL602222S, RSL602223S, RSL602224S, RSL602225S, RSL602227S, RSL602228S, RSL602229S, RSL602230S, RSL602231S, RSL602232S, RSL603256S, RSL603258S, RSL603259S, RSL603260S, RSL603261S, RSL601338S, RSL601339S, RSL601386S, RSL601434S, RSL601624S, RSL601626S, RSL601627S, RSL601628S, RSL601629S, RSL601630S, RSL601631S, RSL601632S, RSL601633S, RSL601634S, RSL601635S, RSL601636S, RSL602812S, RSL601370S, RSL601642S, RSL603153S, RSL602352S, RSL602422S, RSL602807S, RSL603126S, RSL603207S, RSL600336S, RSL600344S, RSL600407S, RSL600429S, RSL600809S, RSL601609S, RSL601698S, RSL601730S, RSL601800S, RSL601996S, RSL602171S, RSL602189S, RSL603606S, RSL602932S, RSL603159S, RSL603160S, RSL603253S, RSL603096S, RSL601651S, RSL601983S, RSL603133S, RSL601441S, RSL602289S, RSL602336S, RSL600605S, RSL601938S, RSL602067S, RSL602559S, RSL603597S, RSL603598S, RSL601708S, RSL…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1721-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1721-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; 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 00763000178338, Lot Serial Numbers: RSL602442S, RSL601336S, RSL600186S, RSL602060S, RSL601499S, RSL601501S, RSL602893S, RSL602901S, RSL602941S, RSL602955S, RSL602420S, RSL602899S, RSL601490S, RSL602690S, RSL600167S, RSL600499S, RSL600561S, RSL600563S, RSL600564S, RSL600565S, RSL601867S, RSL601868S, RSL601870S, RSL601966S, RSL603729S, RSL601838S, RSL602889S, RSL600163S, RSL602444S, RSL602823S, RSL602826S, RSL603092S, RSL603105S, RSL603233S, RSL603237S, RSL603565S, RSL600206S, RSL600230S, RSL600231S, RSL601723S, RSL601789S, RSL601878S, RSL602705S, RSL602854S, RSL602828S, RSL602933S, RSL603236S, RSL601484S, RSL601988S, RSL603618S, RSL602324S, RSL602979S, RSL603759S, RSL600237S, RSL601990S, RSL600172S, RSL602465S, RSL602466S, RSL602467S, RSL602468S, RSL602469S, RSL602470S, RSL602471S, RSL602472S, RSL602892S, RSL603257S, RSL603262S, RSL603263S, RSL603264S, RSL601873S, RSL601874S, RSL601875S, RSL601876S, RSL601887S, RSL601895S, RSL602043S, RSL602044S, RSL602045S, RSL602046S, RSL602047S, RSL602048S, RSL602049S, RSL602050S, RSL602051S, RSL602052S, RSL602053S, RSL602054S, RSL602055S, RSL602056S, RSL602058S, RSL602059S, RSL602221S, RSL602222S, RSL602223S, RSL602224S, RSL602225S, RSL602227S, RSL602228S, RSL602229S, RSL602230S, RSL602231S, RSL602232S, RSL603256S, RSL603258S, RSL603259S, RSL603260S, RSL603261S, RSL601338S, RSL601339S…
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-1721-2023 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.