ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
type: Dataset
description: FDA recall Z-1707-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; 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-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
  type: MedicalDevice
  manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
claims: FDA recall Z-1707-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
claims: FDA classified recall Z-1707-2023 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1707-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1707-2023
      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 00643169217911, Lot Serial Numbers: BWE613480S, BWE613110S, BWE613432S, BWE613202S, BWE613100S, BWE613096S, BWE613185S, BWE613258S, BWE613431S, BWE612802S, BWE612865S, BWE613214S, BWE613235S, BWE612884S, BWE612956S, BWE613098S, BWE613122S, BWE613143S, BWE613171S, BWE613212S, BWE613216S, BWE613251S, BWE613470S, BWE613162S, BWE613238S, BWE613459S, BWE613430S, BWE613153S, BWE613484S, BWE613168S, BWE612948S, BWE612950S, BWE612970S, BWE613487S, BWE613090S, BWE613224S, BWE613180S, BWE613077S, BWE612815S, BWE612940S, BWE613086S, BWE612721S, BWE613194S, BWE612880S, BWE613125S, BWE613221S, BWE612822S, BWE612985S, BWE612928S, BWE613446S, BWE612939S, BWE612837S, BWE613097S, BWE613095S, BWE613104S, BWE613211S, BWE613463S, BWE613460S, BWE612679S, BWE612960S, BWE613149S, BWE613150S, BWE613247S, BWE612981S, BWE612987S, BWE613145S, BWE613147S, BWE613485S, BWE612986S, BWE613443S, BWE612844S, BWE612686S, BWE612824S, BWE612853S, BWE612923S, BWE612976S, BWE612935S, BWE612982S, BWE612993S, BWE613155S, BWE613124S, BWE612930S, BWE612949S, BWE612833S, BWE613115S, BWE613182S, BWE613121S, BWE612922S, BWE612990S, BWE613197S, BWE612801S, BWE612988S, BWE613111S, BWE613116S, BWE613146S, BWE613183S, BWE613352S, BWE613141S, BWE613466S, BWE612675S, BWE612785S, BWE612796S, BWE612961S, BWE613089S, BWE613101S, BWE613250S, BWE613253S, BWE613448S, BWE613467S, BWE612978S, BWE612685S, BWE612974S, BWE612876S, BWE612917S, BWE612977S, BWE613082S, BWE613102S, BWE613156S, BWE613441S, BWE613444S, BWE613473S, BWE613172S, BWE612791S, BWE612792S, BWE612793S, BWE612794S, BWE612795S, BWE612797S, BWE612798S, BWE612799S, BWE612800S, BWE612893S, BWE612900S, BWE612954S, BWE612957S, BWE613259S, BWE612953S, BWE613181S, BWE613472S, BWE613195S, BWE613468S, BWE613433S, BWE613084S, BWE613201S, BWE613469S, BWE612827S, BWE613088S, BWE613184S, BWE612963S, BWE612983S, BWE613126S, BWE613215S, BWE613445S, BWE613471S, BWE612823S, BWE612840S, BWE612932S, BWE612885S, BWE612769S, BWE613196S, BWE613140S, BWE613229S, BWE612779S, BWE…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide - Worldwide Distribution
      status: recorded

FDA recall Z-1707-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
type: Claim
text: The FDA logged enforcement record Z-1707-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; 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 00643169217911, Lot Serial Numbers: BWE613480S, BWE613110S, BWE613432S, BWE613202S, BWE613100S, BWE613096S, BWE613185S, BWE613258S, BWE613431S, BWE612802S, BWE612865S, BWE613214S, BWE613235S, BWE612884S, BWE612956S, BWE613098S, BWE613122S, BWE613143S, BWE613171S, BWE613212S, BWE613216S, BWE613251S, BWE613470S, BWE613162S, BWE613238S, BWE613459S, BWE613430S, BWE613153S, BWE613484S, BWE613168S, BWE612948S, BWE612950S, BWE612970S, BWE613487S, BWE613090S, BWE613224S, BWE613180S, BWE613077S, BWE612815S, BWE612940S, BWE613086S, BWE612721S, BWE613194S, BWE612880S, BWE613125S, BWE613221S, BWE612822S, BWE612985S, BWE612928S, BWE613446S, BWE612939S, BWE612837S, BWE613097S, BWE613095S, BWE613104S, BWE613211S, BWE613463S, BWE613460S, BWE612679S, BWE612960S, BWE613149S, BWE613150S, BWE613247S, BWE612981S, BWE612987S, BWE613145S, BWE613147S, BWE613485S, BWE612986S, BWE613443S, BWE612844S, BWE612686S, BWE612824S, BWE612853S, BWE612923S, BWE612976S, BWE612935S, BWE612982S, BWE612993S, BWE613155S, BWE613124S, BWE612930S, BWE612949S, BWE612833S, BWE613115S, BWE613182S, BWE613121S, BWE612922S, BWE612990S, BWE613197S, BWE612801S, BWE612988S, BWE613111S, BWE613116S, BWE613146S, BWE613183S, BWE613352S, BWE613141S, BWE613466S, BWE612675S, BWE612785S, BWE612796S, BWE612961S, BWE613089S, BWE613101S, BWE613250S, BWE613253S, BWE613448S, BW…
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-1707-2023 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.