CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1774-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; 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 MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1774-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1774-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1774-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1774-2023
      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 00763000178147, Lot Serial numbers: RTH601483S, RTH602021S, RTH602022S, RTH602302S, RTH602303S, RTH602305S, RTH602306S, RTH605169S, RTH602089S, RTH603993S, RTH601526S, RTH600467S, RTH600514S, RTH600533S, RTH600607S, RTH600608S, RTH601387S, RTH601543S, RTH601544S, RTH601545S, RTH602017S, RTH605116S, RTH600520S, RTH602108S, RTH604790S, RTH602149S, RTH605081S, RTH605082S, RTH604360S, RTH604780S, RTH604943S, RTH604734S, RTH600153S, RTH601390S, RTH601395S, RTH601849S, RTH601868S, RTH602192S, RTH602619S, RTH600554S, RTH602035S, RTH602694S, RTH600170S, RTH602206S, RTH601611S, RTH602091S, RTH602195S, RTH603628S, RTH600220S, RTH600223S, RTH600228S, RTH600288S, RTH601447S, RTH601448S, RTH601449S, RTH601450S, RTH602055S, RTH602056S, RTH602057S, RTH602058S, RTH602059S, RTH602060S, RTH602061S, RTH602064S, RTH602065S, RTH602067S, RTH602069S, RTH602071S, RTH602072S, RTH602073S, RTH602074S, RTH602077S, RTH602078S, RTH602079S, RTH602271S, RTH602272S, RTH602276S, RTH602277S, RTH602288S, RTH602625S, RTH602626S, RTH602627S, RTH602628S, RTH602629S, RTH602630S, RTH602631S, RTH602632S, RTH602633S, RTH602634S, RTH602635S, RTH602639S, RTH602640S, RTH602641S, RTH602642S, RTH602643S, RTH602645S, RTH602646S, RTH603959S, RTH603977S, RTH603986S, RTH604454S, RTH604455S, RTH604456S, RTH600592S, RTH601482S, RTH601553S, RTH601555S, RTH601556S, RTH601558S, RTH601563S, RTH601564S, RTH601567S, RTH602618S, RTH601756S, RTH601641S, RTH600460S, RTH601716S, RTH601948S, RTH602517S, RTH600294S, RTH600472S, RTH600475S, RTH601454S, RTH601541S, RTH601633S, RTH601761S, RTH601885S, RTH602042S, RTH602592S, RTH602623S, RTH601518S, RTH602085S, RTH602267S, RTH602686S, RTH605142S, RTH600428S, RTH600449S, RTH601687S, RTH602137S, RTH602144S, RTH602148S, RTH602240S, RTH602260S, RTH601936S, RTH605049S, RTH605053S, RTH600120S, RTH600359S, RTH601663S, RTH601666S, RTH601704S, RTH601793S, RTH600184S, RTH600530S, RTH602053S, RTH602682S, RTH601420S, RTH601422S, RTH602043S, RTH602046S, RTH602048S, RTH602051S, RTH602647S, RTH…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1774-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1774-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; 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 00763000178147, Lot Serial numbers: RTH601483S, RTH602021S, RTH602022S, RTH602302S, RTH602303S, RTH602305S, RTH602306S, RTH605169S, RTH602089S, RTH603993S, RTH601526S, RTH600467S, RTH600514S, RTH600533S, RTH600607S, RTH600608S, RTH601387S, RTH601543S, RTH601544S, RTH601545S, RTH602017S, RTH605116S, RTH600520S, RTH602108S, RTH604790S, RTH602149S, RTH605081S, RTH605082S, RTH604360S, RTH604780S, RTH604943S, RTH604734S, RTH600153S, RTH601390S, RTH601395S, RTH601849S, RTH601868S, RTH602192S, RTH602619S, RTH600554S, RTH602035S, RTH602694S, RTH600170S, RTH602206S, RTH601611S, RTH602091S, RTH602195S, RTH603628S, RTH600220S, RTH600223S, RTH600228S, RTH600288S, RTH601447S, RTH601448S, RTH601449S, RTH601450S, RTH602055S, RTH602056S, RTH602057S, RTH602058S, RTH602059S, RTH602060S, RTH602061S, RTH602064S, RTH602065S, RTH602067S, RTH602069S, RTH602071S, RTH602072S, RTH602073S, RTH602074S, RTH602077S, RTH602078S, RTH602079S, RTH602271S, RTH602272S, RTH602276S, RTH602277S, RTH602288S, RTH602625S, RTH602626S, RTH602627S, RTH602628S, RTH602629S, RTH602630S, RTH602631S, RTH602632S, RTH602633S, RTH602634S, RTH602635S, RTH602639S, RTH602640S, RTH602641S, RTH602642S, RTH602643S, RTH602645S, RTH602646S, RTH603959S, RTH603977S, RTH603986S, RTH604454S, RTH604455S, RTH604456S, RTH600592S, RTH601482S, RTH601553S, RTH601555S, RTH601556S, RTH601558…
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-1774-2023 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.