ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1726-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; 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 DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1726-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1726-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1726-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1726-2023
      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 00763000178390, Lot Serial Numbers: RSO600207S, RSO600934S, RSO602587S, RSO602860S, RSO603892S, RSO600679S, RSO612257S, RSO602636S, RSO604992S, RSO609567S, RSO609647S, RSO609795S, RSO609900S, RSO610931S, RSO607136S, RSO609278S, RSO601095S, RSO601096S, RSO601098S, RSO601472S, RSO601473S, RSO601474S, RSO601475S, RSO601476S, RSO601477S, RSO601478S, RSO601479S, RSO604357S, RSO604358S, RSO605928S, RSO606135S, RSO606155S, RSO603632S, RSO603681S, RSO607412S, RSO607605S, RSO610650S, RSO600968S, RSO601258S, RSO603258S, RSO603300S, RSO603339S, RSO603742S, RSO603773S, RSO612385S, RSO601910S, RSO601911S, RSO601913S, RSO602604S, RSO602611S, RSO603824S, RSO603826S, RSO603876S, RSO609857S, RSO610204S, RSO609865S, RSO610317S, RSO601050S, RSO601392S, RSO601568S, RSO601741S, RSO604464S, RSO600230S, RSO610679S, RSO612158S, RSO612159S, RSO608401S, RSO608413S, RSO613154S, RSO613155S, RSO609928S, RSO610881S, RSO611808S, RSO600081S, RSO600082S, RSO600083S, RSO600951S, RSO600986S, RSO601604S, RSO604972S, RSO605522S, RSO606607S, RSO607741S, RSO606041S, RSO601440S, RSO605663S, RSO607178S, RSO607206S, RSO609698S, RSO603723S, RSO602519S, RSO603022S, RSO603027S, RSO603552S, RSO603805S, RSO603832S, RSO603833S, RSO604179S, RSO604194S, RSO604476S, RSO604477S, RSO604521S, RSO604971S, RSO604986S, RSO605288S, RSO605313S, RSO606154S, RSO606633S, RSO606984S, RSO607027S, RSO607059S, RSO607060S, RSO607066S, RSO607258S, RSO609917S, RSO601016S, RSO602843S, RSO603638S, RSO603828S, RSO603945S, RSO604008S, RSO604027S, RSO604176S, RSO607364S, RSO607365S, RSO608201S, RSO600768S, RSO602527S, RSO601005S, RSO601737S, RSO610417S, RSO601500S, RSO610630S, RSO612087S, RSO612192S, RSO612270S, RSO612547S, RSO610576S, RSO611766S, RSO611771S, RSO611773S, RSO600905S, RSO601136S, RSO601571S, RSO602734S, RSO603672S, RSO605325S, RSO606464S, RSO606516S, RSO607087S, RSO607179S, RSO607202S, RSO607203S, RSO607602S, RSO602875S, RSO602876S, RSO602877S, RSO602878S, RSO602880S, RSO602881S, RSO602882S, RSO602883S, RSO602884S, RSO…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1726-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1726-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; 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 00763000178390, Lot Serial Numbers: RSO600207S, RSO600934S, RSO602587S, RSO602860S, RSO603892S, RSO600679S, RSO612257S, RSO602636S, RSO604992S, RSO609567S, RSO609647S, RSO609795S, RSO609900S, RSO610931S, RSO607136S, RSO609278S, RSO601095S, RSO601096S, RSO601098S, RSO601472S, RSO601473S, RSO601474S, RSO601475S, RSO601476S, RSO601477S, RSO601478S, RSO601479S, RSO604357S, RSO604358S, RSO605928S, RSO606135S, RSO606155S, RSO603632S, RSO603681S, RSO607412S, RSO607605S, RSO610650S, RSO600968S, RSO601258S, RSO603258S, RSO603300S, RSO603339S, RSO603742S, RSO603773S, RSO612385S, RSO601910S, RSO601911S, RSO601913S, RSO602604S, RSO602611S, RSO603824S, RSO603826S, RSO603876S, RSO609857S, RSO610204S, RSO609865S, RSO610317S, RSO601050S, RSO601392S, RSO601568S, RSO601741S, RSO604464S, RSO600230S, RSO610679S, RSO612158S, RSO612159S, RSO608401S, RSO608413S, RSO613154S, RSO613155S, RSO609928S, RSO610881S, RSO611808S, RSO600081S, RSO600082S, RSO600083S, RSO600951S, RSO600986S, RSO601604S, RSO604972S, RSO605522S, RSO606607S, RSO607741S, RSO606041S, RSO601440S, RSO605663S, RSO607178S, RSO607206S, RSO609698S, RSO603723S, RSO602519S, RSO603022S, RSO603027S, RSO603552S, RSO603805S, RSO603832S, RSO603833S, RSO604179S, RSO604194S, RSO604476S, RSO604477S, RSO604521S, RSO604971S, RSO604986S, RSO605288S, RSO605313S, RSO606154S, RSO606633S, RSO606984S, R…
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-1726-2023 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.