CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1781-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; 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 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1781-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1781-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1781-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1781-2023
      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 00763000178222, Lot Serial numbers: RTP600502S, RTP602448S, RTP600549S, RTP600551S, RTP600553S, RTP600554S, RTP600555S, RTP601566S, RTP601569S, RTP602731S, RTP602733S, RTP601785S, RTP601786S, RTP601825S, RTP601826S, RTP601620S, RTP602203S, RTP602327S, RTP600744S, RTP600745S, RTP600762S, RTP601117S, RTP601187S, RTP601231S, RTP601906S, RTP603519S, RTP600475S, RTP600228S, RTP600308S, RTP600757S, RTP601116S, RTP601219S, RTP601221S, RTP601723S, RTP601724S, RTP601907S, RTP602117S, RTP602216S, RTP601572S, RTP602154S, RTP602038S, RTP600454S, RTP600670S, RTP601041S, RTP601066S, RTP601209S, RTP601801S, RTP600394S, RTP600397S, RTP600184S, RTP601049S, RTP601072S, RTP601822S, RTP600645S, RTP603289S, RTP603604S, RTP600559S, RTP600796S, RTP601834S, RTP600396S, RTP600738S, RTP600739S, RTP600740S, RTP600741S, RTP601589S, RTP601591S, RTP601595S, RTP601596S, RTP600148S, RTP600700S, RTP600627S, RTP601567S, RTP601186S, RTP601999S, RTP600819S, RTP601857S, RTP600576S, RTP600585S, RTP600779S, RTP600829S, RTP600452S, RTP601850S, RTP602030S, RTP602285S, RTP603440S, RTP600773S, RTP600498S, RTP600970S, RTP602267S, RTP602292S, RTP601227S, RTP600896S, RTP601034S, RTP601035S, RTP602213S, RTP602271S, RTP600671S, RTP600675S, RTP601862S, RTP600509S, RTP601568S, RTP600177S, RTP600093S, RTP600190S, RTP600191S, RTP600192S, RTP600660S, RTP600662S, RTP600663S, RTP600778S, RTP600806S, RTP600917S, RTP601179S, RTP601706S, RTP601707S, RTP601788S, RTP601793S, RTP602028S, RTP602611S, RTP600303S, RTP600647S, RTP600955S, RTP601988S, RTP602217S, RTP602283S, RTP602410S, RTP602413S, RTP601727S, RTP600904S, RTP600914S, RTP600915S, RTP600628S, RTP601232S, RTP602486S, RTP600181S, RTP600689S, RTP601081S, RTP601872S, RTP601982S, RTP602246S, RTP602403S, RTP602429S, RTP602439S, RTP603446S, RTP601830S, RTP601836S, RTP602088S, RTP602105S, RTP602124S, RTP603381S, RTP600701S, RTP601879S, RTP602405S, RTP600283S, RTP600284S, RTP600430S, RTP600634S, RTP600766S, RTP600816S, RTP600854S, RTP601884S, RTP602166S, RTP602168S, RTP…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1781-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1781-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; 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 00763000178222, Lot Serial numbers: RTP600502S, RTP602448S, RTP600549S, RTP600551S, RTP600553S, RTP600554S, RTP600555S, RTP601566S, RTP601569S, RTP602731S, RTP602733S, RTP601785S, RTP601786S, RTP601825S, RTP601826S, RTP601620S, RTP602203S, RTP602327S, RTP600744S, RTP600745S, RTP600762S, RTP601117S, RTP601187S, RTP601231S, RTP601906S, RTP603519S, RTP600475S, RTP600228S, RTP600308S, RTP600757S, RTP601116S, RTP601219S, RTP601221S, RTP601723S, RTP601724S, RTP601907S, RTP602117S, RTP602216S, RTP601572S, RTP602154S, RTP602038S, RTP600454S, RTP600670S, RTP601041S, RTP601066S, RTP601209S, RTP601801S, RTP600394S, RTP600397S, RTP600184S, RTP601049S, RTP601072S, RTP601822S, RTP600645S, RTP603289S, RTP603604S, RTP600559S, RTP600796S, RTP601834S, RTP600396S, RTP600738S, RTP600739S, RTP600740S, RTP600741S, RTP601589S, RTP601591S, RTP601595S, RTP601596S, RTP600148S, RTP600700S, RTP600627S, RTP601567S, RTP601186S, RTP601999S, RTP600819S, RTP601857S, RTP600576S, RTP600585S, RTP600779S, RTP600829S, RTP600452S, RTP601850S, RTP602030S, RTP602285S, RTP603440S, RTP600773S, RTP600498S, RTP600970S, RTP602267S, RTP602292S, RTP601227S, RTP600896S, RTP601034S, RTP601035S, RTP602213S, RTP602271S, RTP600671S, RTP600675S, RTP601862S, RTP600509S, RTP601568S, RTP600177S, RTP600093S, RTP600190S, RTP600191S, RTP600192S, RTP600660S, RTP600662S, RTP600663S, …
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-1781-2023 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.