CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1778-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; 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: CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1778-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1778-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1778-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1778-2023
      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 00763000178109, Lot Serial numbers: RTD602437S, RTD602300S, RTD602301S, RTD602414S, RTD602417S, RTD602418S, RTD602419S, RTD601286S, RTD600407S, RTD600686S, RTD600687S, RTD600688S, RTD600689S, RTD601807S, RTD602096S, RTD602321S, RTD601977S, RTD600375S, RTD600427S, RTD600818S, RTD601290S, RTD601294S, RTD601304S, RTD603210S, RTD601610S, RTD601791S, RTD600469S, RTD601931S, RTD601498S, RTD601499S, RTD601778S, RTD602158S, RTD602232S, RTD602015S, RTD602249S, RTD603182S, RTD601298S, RTD600498S, RTD603371S, RTD600756S, RTD602093S, RTD601471S, RTD601517S, RTD601525S, RTD601526S, RTD601532S, RTD601534S, RTD601535S, RTD601551S, RTD601552S, RTD601843S, RTD601844S, RTD601846S, RTD601849S, RTD601851S, RTD601852S, RTD601853S, RTD601855S, RTD601857S, RTD601858S, RTD601859S, RTD601861S, RTD601862S, RTD601878S, RTD601895S, RTD601907S, RTD601913S, RTD601914S, RTD601915S, RTD601916S, RTD601933S, RTD601935S, RTD601936S, RTD601937S, RTD601942S, RTD601985S, RTD602052S, RTD602053S, RTD602054S, RTD602055S, RTD602056S, RTD602058S, RTD602059S, RTD602060S, RTD602061S, RTD602062S, RTD602063S, RTD602064S, RTD602065S, RTD602066S, RTD602067S, RTD602272S, RTD602273S, RTD602274S, RTD602276S, RTD602278S, RTD602279S, RTD602280S, RTD602281S, RTD602282S, RTD602283S, RTD602284S, RTD602285S, RTD602287S, RTD602288S, RTD602289S, RTD602291S, RTD602292S, RTD602293S, RTD602294S, RTD602295S, RTD602296S, RTD602297S, RTD602298S, RTD603153S, RTD603945S, RTD603947S, RTD603949S, RTD603950S, RTD604012S, RTD604013S, RTD604014S, RTD600837S, RTD601307S, RTD601309S, RTD601447S, RTD601448S, RTD601644S, RTD601659S, RTD601661S, RTD601665S, RTD601695S, RTD601696S, RTD601713S, RTD601714S, RTD601715S, RTD601728S, RTD600709S, RTD601438S, RTD601472S, RTD602397S, RTD603911S, RTD600434S, RTD600398S, RTD600413S, RTD600562S, RTD600583S, RTD600744S, RTD601340S, RTD601683S, RTD601711S, RTD602013S, RTD603410S, RTD603411S, RTD603502S, RTD601460S, RTD602234S, RTD602268S, RTD601367S, RTD601423S, RTD602111S, RTD602132S, RTD600527S, RTD…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1778-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1778-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; 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 00763000178109, Lot Serial numbers: RTD602437S, RTD602300S, RTD602301S, RTD602414S, RTD602417S, RTD602418S, RTD602419S, RTD601286S, RTD600407S, RTD600686S, RTD600687S, RTD600688S, RTD600689S, RTD601807S, RTD602096S, RTD602321S, RTD601977S, RTD600375S, RTD600427S, RTD600818S, RTD601290S, RTD601294S, RTD601304S, RTD603210S, RTD601610S, RTD601791S, RTD600469S, RTD601931S, RTD601498S, RTD601499S, RTD601778S, RTD602158S, RTD602232S, RTD602015S, RTD602249S, RTD603182S, RTD601298S, RTD600498S, RTD603371S, RTD600756S, RTD602093S, RTD601471S, RTD601517S, RTD601525S, RTD601526S, RTD601532S, RTD601534S, RTD601535S, RTD601551S, RTD601552S, RTD601843S, RTD601844S, RTD601846S, RTD601849S, RTD601851S, RTD601852S, RTD601853S, RTD601855S, RTD601857S, RTD601858S, RTD601859S, RTD601861S, RTD601862S, RTD601878S, RTD601895S, RTD601907S, RTD601913S, RTD601914S, RTD601915S, RTD601916S, RTD601933S, RTD601935S, RTD601936S, RTD601937S, RTD601942S, RTD601985S, RTD602052S, RTD602053S, RTD602054S, RTD602055S, RTD602056S, RTD602058S, RTD602059S, RTD602060S, RTD602061S, RTD602062S, RTD602063S, RTD602064S, RTD602065S, RTD602066S, RTD602067S, RTD602272S, RTD602273S, RTD602274S, RTD602276S, RTD602278S, RTD602279S, RTD602280S, RTD602281S, RTD602282S, RTD602283S, RTD602284S, RTD602285S, RTD602287S, RTD602288S, RTD602289S, RTD602291S, RTD602292S, RTD6…
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-1778-2023 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.