CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1782-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; 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 HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1782-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1782-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1782-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1782-2023
      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 00763000178215, Lot Serial Numbers: RTO600161S, RTO600247S, RTO601140S, RTO601641S, RTO602045S, RTO602335S, RTO602270S, RTO600314S, RTO601040S, RTO601383S, RTO600175S, RTO600229S, RTO600417S, RTO600458S, RTO600507S, RTO600650S, RTO601039S, RTO602060S, RTO603798S, RTO600463S, RTO601433S, RTO601826S, RTO601973S, RTO602476S, RTO601038S, RTO601148S, RTO601171S, RTO601248S, RTO602261S, RTO601481S, RTO600833S, RTO601285S, RTO601310S, RTO601556S, RTO600393S, RTO602484S, RTO600262S, RTO600681S, RTO601538S, RTO600380S, RTO600384S, RTO601944S, RTO602394S, RTO602445S, RTO600968S, RTO601037S, RTO601565S, RTO600218S, RTO601309S, RTO601311S, RTO601453S, RTO603333S, RTO600332S, RTO600493S, RTO601704S, RTO601798S, RTO601954S, RTO601983S, RTO602442S, RTO601808S, RTO601986S, RTO602037S, RTO600385S, RTO600435S, RTO601216S, RTO601220S, RTO601630S, RTO601735S, RTO601244S, RTO601307S, RTO601308S, RTO601043S, RTO602304S, RTO600445S, RTO600450S, RTO601513S, RTO601618S, RTO601942S, RTO600251S, RTO601520S, RTO600716S, RTO600464S, RTO601650S, RTO600151S, RTO600363S, RTO601008S, RTO600267S, RTO600268S, RTO600571S, RTO600605S, RTO600640S, RTO602065S, RTO600244S, RTO600634S, RTO602301S, RTO602309S, RTO600283S, RTO601834S, RTO602047S, RTO602593S, RTO601959S, RTO601109S, RTO601586S, RTO602128S, RTO602485S, RTO602486S, RTO602542S, RTO602121S, RTO600657S, RTO600729S, RTO600730S, RTO600731S, RTO601325S, RTO601490S, RTO601491S, RTO601493S, RTO601558S, RTO601560S, RTO601561S, RTO601562S, RTO601049S, RTO601118S, RTO601922S, RTO602290S, RTO602291S, RTO602579S, RTO603682S, RTO601978S, RTO602382S, RTO600717S, RTO600718S, RTO601029S, RTO601769S, RTO602005S, RTO602072S, RTO602296S, RTO600121S, RTO600321S, RTO600341S, RTO600343S, RTO600420S, RTO601165S, RTO601637S, RTO601760S, RTO601761S, RTO601817S, RTO601925S, RTO601943S, RTO601955S, RTO602073S, RTO602125S, RTO602206S, RTO602275S, RTO602286S, RTO602357S, RTO602358S, RTO602448S, RTO602455S, RTO602526S, RTO602527S, RTO602565S, RTO602566S, RTO600471S, RTO…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1782-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1782-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; 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 00763000178215, Lot Serial Numbers: RTO600161S, RTO600247S, RTO601140S, RTO601641S, RTO602045S, RTO602335S, RTO602270S, RTO600314S, RTO601040S, RTO601383S, RTO600175S, RTO600229S, RTO600417S, RTO600458S, RTO600507S, RTO600650S, RTO601039S, RTO602060S, RTO603798S, RTO600463S, RTO601433S, RTO601826S, RTO601973S, RTO602476S, RTO601038S, RTO601148S, RTO601171S, RTO601248S, RTO602261S, RTO601481S, RTO600833S, RTO601285S, RTO601310S, RTO601556S, RTO600393S, RTO602484S, RTO600262S, RTO600681S, RTO601538S, RTO600380S, RTO600384S, RTO601944S, RTO602394S, RTO602445S, RTO600968S, RTO601037S, RTO601565S, RTO600218S, RTO601309S, RTO601311S, RTO601453S, RTO603333S, RTO600332S, RTO600493S, RTO601704S, RTO601798S, RTO601954S, RTO601983S, RTO602442S, RTO601808S, RTO601986S, RTO602037S, RTO600385S, RTO600435S, RTO601216S, RTO601220S, RTO601630S, RTO601735S, RTO601244S, RTO601307S, RTO601308S, RTO601043S, RTO602304S, RTO600445S, RTO600450S, RTO601513S, RTO601618S, RTO601942S, RTO600251S, RTO601520S, RTO600716S, RTO600464S, RTO601650S, RTO600151S, RTO600363S, RTO601008S, RTO600267S, RTO600268S, RTO600571S, RTO600605S, RTO600640S, RTO602065S, RTO600244S, RTO600634S, RTO602301S, RTO602309S, RTO600283S, RTO601834S, RTO602047S, RTO602593S, RTO601959S, RTO601109S, RTO601586S, RTO602128S, RTO602485S, RTO602486S, RTO602542S, RTO602121S, RTO600657S, …
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-1782-2023 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.