Model Number L100, ESSENTIO SR SL Pacemaker
type: Dataset
description: FDA recall Z-0092-2026 — Boston Scientific Corporation is recalling Model Number L100, ESSENTIO SR 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 L100, ESSENTIO SR SL Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0092-2026: Boston Scientific Corporation is recalling Model Number L100, ESSENTIO SR SL Pacemaker
claims: FDA classified recall Z-0092-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0092-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0092-2026
      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 00802526559150, Serial Numbers: 464853, 464855, 464865, 464866, 464867, 464868, 464871, 464872, 464874, 464879, 464881, 464882, 464886, 464896, 464907, 464911, 464912, 464913, 464914, 464915, 464916, 464917, 464919, 464921, 464922, 464925, 464927, 464929, 464930, 464935, 464937, 464938, 464939, 464940, 464941, 464947, 464948, 464955, 464956, 464957, 464960, 464962, 464966, 464967, 464970, 464971, 464972, 464977, 464978, 464979, 464980, 464982, 464983, 464988, 464991, 464997, 464998, 464999, 465004, 465005, 465006, 465007, 465009, 465011, 465012, 465014, 465015, 465019, 465025, 465026, 465027, 465029, 465032, 465037, 465038, 465041, 465043, 465044, 465046, 465049, 465050, 465053, 465054, 465055, 465056, 465057, 465060, 465061, 465062, 465063, 465064, 465065, 465067, 465069, 465070, 465072, 465075, 465076, 465078, 465079, 465081, 465084, 465085, 465088, 465089, 465092, 465093, 465097, 465102, 465103, 465104, 465105, 465106, 465113, 465116, 465123, 465126, 465128, 465132, 465133, 465134, 465135, 465136, 465138, 465145, 465148, 465149, 465150, 465151, 465152, 465153, 465154, 465158, 465161, 465162, 465163, 465165, 465169, 465170, 465173, 465176, 465183, 465188, 465189, 465192, 465193, 465194, 465199, 465201, 465206, 465208, 465213, 465226, 465234, 465238, 465248, 465249, 465264, 465281, 465290, 465292, 465293, 465301, 465302, 465304, 465314, 465351, 465352, 465377, 465382, 465385, 465399, 465408, 465412, 465415, 465417, 465419, 465425, 465427, 465434, 465441, 465442, 465445, 465447, 465448, 465454, 465458, 465460, 465463, 465464, 465465, 465466, 465468, 465470, 465471, 465473, 465477, 465478, 465481, 465483, 465485, 465487, 465488, 465489, 465493, 465494, 465495, 465496, 465497, 465498, 465502, 465503, 465506, 465508, 465509, 465510, 465511, 465512, 465515, 465518, 465521, 465522, 465525, 465526, 465528, 465529, 465532, 465534, 465535, 465536, 465537, 465538, 465539, 465540, 465541, 465543, 465544, 465546, 465547, 465551, 465552, 465554, 465555, 465556, 465557, 465…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0092-2026: Boston Scientific Corporation is recalling Model Number L100, ESSENTIO SR SL Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0092-2026: Boston Scientific Corporation is voluntarily recalling Model Number L100, ESSENTIO SR 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 00802526559150, Serial Numbers: 464853, 464855, 464865, 464866, 464867, 464868, 464871, 464872, 464874, 464879, 464881, 464882, 464886, 464896, 464907, 464911, 464912, 464913, 464914, 464915, 464916, 464917, 464919, 464921, 464922, 464925, 464927, 464929, 464930, 464935, 464937, 464938, 464939, 464940, 464941, 464947, 464948, 464955, 464956, 464957, 464960, 464962, 464966, 464967, 464970, 464971, 464972, 464977, 464978, 464979, 464980, 464982, 464983, 464988, 464991, 464997, 464998, 464999, 465004, 465005, 465006, 465007, 465009, 465011, 465012, 465014, 465015, 465019, 465025, 465026, 465027, 465029, 465032, 465037, 465038, 465041, 465043, 465044, 465046, 465049, 465050, 465053, 465054, 465055, 465056, 465057, 465060, 465061, 465062, 465063, 465064, 465065, 465067, 465069, 465070, 465072, 465075, 465076, 465078, 465079, 465081, 465084, 465085, 465088, 465089, 465092, 465093, 465097, 465102, 465103, 465104, 465105, 465106, 465113, 465116, 465123, 465126, 465128, 465132, 465133, 465134, 465135, 465136, 465138, 465145, 465148, 465149, 465150, 465151, 465152, 465153, 465154, 465158, 465161, 465162, 465163, 465165, 465169, 465170, 465173, 465176, 465183, 465188, 465189, 465192, 465193, 465194, 465199, 465201, 465206, 465208, 465213, 465226, 465234, 465238, 465248, 465249, 465264, 465281, 465290, 465292, …
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-0092-2026 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.