Model Number L101, ESSENTIO DR SL Pacemaker
type: Dataset
description: FDA recall Z-0093-2026 — Boston Scientific Corporation is recalling Model Number L101, ESSENTIO DR SL Pacemaker (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: Model Number L101, ESSENTIO DR SL Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0093-2026: Boston Scientific Corporation is recalling Model Number L101, ESSENTIO DR SL Pacemaker
claims: FDA classified recall Z-0093-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0093-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0093-2026
      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: Boston Scientific Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-08-20
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: GTIN 00802526559174, Serial Numbers: 100547, 100752, 100822, 100843, 100852, 100853, 100857, 100863, 100865, 100866, 100868, 100871, 100874, 100879, 100883, 100884, 100889, 100891, 100892, 100893, 100897, 100900, 100914, 100915, 100916, 100919, 100923, 100925, 100927, 100928, 100931, 100932, 100938, 100941, 100942, 100944, 100948, 100949, 100952, 100955, 100956, 100957, 100962, 100969, 100970, 100972, 100973, 100980, 100981, 100982, 100985, 100986, 100988, 100989, 100990, 100991, 100993, 100995, 100996, 101000, 101002, 101003, 101004, 101006, 101012, 101014, 101015, 101016, 101017, 101020, 101021, 101022, 101024, 101025, 101033, 101036, 101037, 101042, 101044, 101048, 101050, 101052, 101053, 101059, 101061, 101063, 101067, 101073, 101074, 101075, 101076, 101087, 101090, 101092, 101093, 101096, 101097, 101098, 101105, 101106, 101108, 101109, 101110, 101111, 101113, 101120, 101125, 101126, 101127, 101129, 101130, 101131, 101132, 101136, 101138, 101141, 101144, 101148, 101149, 101154, 101155, 101157, 101158, 101170, 101174, 101177, 101179, 101180, 101184, 101185, 101186, 101187, 101190, 101200, 101202, 101207, 101208, 101214, 101221, 101223, 101224, 101225, 101228, 101229, 101234, 101235, 101236, 101238, 101242, 101244, 101245, 101246, 101249, 101258, 101261, 101262, 101271, 101272, 101274, 101283, 101286, 101297, 101299, 101303, 101309, 101313, 101314, 101315, 101316, 101318, 101322, 101328, 101334, 101336, 101348, 101354, 101359, 101361, 101372, 101379, 101380, 101382, 101388, 101393, 101400, 101406, 101409, 101411, 101412, 101418, 101423, 101424, 101427, 101436, 101438, 101440, 101442, 101450, 101454, 101459, 101466, 101469, 101472, 101475, 101492, 101493, 101511, 101524, 101525, 101529, 101537, 101541, 101543, 101545, 101546, 101553, 101555, 101559, 101560, 101564, 101572, 101575, 101576, 101577, 101579, 101585, 101588, 101602, 101603, 101604, 101605, 101607, 101609, 101611, 101619, 101625, 101633, 101634, 101637, 101638, 101640, 101642, 101644, 101648, 101654, 101…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0093-2026: Boston Scientific Corporation is recalling Model Number L101, ESSENTIO DR SL Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0093-2026: Boston Scientific Corporation is voluntarily recalling Model Number L101, ESSENTIO DR SL Pacemaker — reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-20. Affected lots/codes: GTIN 00802526559174, Serial Numbers: 100547, 100752, 100822, 100843, 100852, 100853, 100857, 100863, 100865, 100866, 100868, 100871, 100874, 100879, 100883, 100884, 100889, 100891, 100892, 100893, 100897, 100900, 100914, 100915, 100916, 100919, 100923, 100925, 100927, 100928, 100931, 100932, 100938, 100941, 100942, 100944, 100948, 100949, 100952, 100955, 100956, 100957, 100962, 100969, 100970, 100972, 100973, 100980, 100981, 100982, 100985, 100986, 100988, 100989, 100990, 100991, 100993, 100995, 100996, 101000, 101002, 101003, 101004, 101006, 101012, 101014, 101015, 101016, 101017, 101020, 101021, 101022, 101024, 101025, 101033, 101036, 101037, 101042, 101044, 101048, 101050, 101052, 101053, 101059, 101061, 101063, 101067, 101073, 101074, 101075, 101076, 101087, 101090, 101092, 101093, 101096, 101097, 101098, 101105, 101106, 101108, 101109, 101110, 101111, 101113, 101120, 101125, 101126, 101127, 101129, 101130, 101131, 101132, 101136, 101138, 101141, 101144, 101148, 101149, 101154, 101155, 101157, 101158, 101170, 101174, 101177, 101179, 101180, 101184, 101185, 101186, 101187, 101190, 101200, 101202, 101207, 101208, 101214, 101221, 101223, 101224, 101225, 101228, 101229, 101234, 101235, 101236, 101238, 101242, 101244, 101245, 101246, 101249, 101258, 101261, 101262, 101271, 101272, 101274, 101283, 101286, …
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-0093-2026 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.