ACCOLADE SR SL (Model L300)
type: Dataset
description: FDA recall Z-0079-2026 — Boston Scientific Corporation is recalling ACCOLADE SR SL (Model L300) (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: ACCOLADE SR SL (Model L300)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0079-2026: Boston Scientific Corporation is recalling ACCOLADE SR SL (Model L300)
claims: FDA classified recall Z-0079-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0079-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0079-2026
      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 00802526558900, Serial Numbers: 464190, 464192, 464197, 464228, 464229, 464230, 464238, 464258, 464279, 464295, 464296, 464316, 464321, 464358, 464360, 464361, 464362, 464363, 464369, 464371, 464378, 464383, 464384, 464392, 464393, 464398, 464400, 464406, 464408, 464409, 464410, 464411, 464414, 464425, 464427, 464430, 464432, 464435, 464437, 464441, 464442, 464443, 464451, 464455, 464456, 464466, 464469, 464474, 464480, 464484, 464485, 464487, 464488, 464489, 464496, 464502, 464503, 464504, 464507, 464520, 464529, 464531, 464534, 464538, 464544, 464547, 464551, 464556, 464558, 464560, 464566, 464571, 464577, 464583, 464585, 464586, 464587, 464588, 464591, 464592, 464604, 464608, 464611, 464617, 464623, 464635, 464637, 464639, 464642, 464643, 464653, 464660, 464662, 464664, 464665, 464667, 464668, 464681, 464683, 464685, 464692, 464697, 464698, 464699, 464700, 464706, 464707, 464708, 464712, 464715, 464720, 464721, 464726, 464730, 464734, 464736, 464738, 464740, 464741, 464743, 464744, 464745, 464746, 464749, 464750, 464751, 464754, 464758, 464761, 464766, 464767, 464771, 464772, 464774, 464775, 464776, 464778, 464779, 464781, 464784, 464787, 464788, 464795, 464796, 464797, 464800, 464805, 464806, 464807, 464810, 464811, 464821, 464824, 464825, 464828, 464830, 464831, 464833, 464837, 464838, 464843, 464848, 464852, 464857, 464858, 464859, 464860, 464870, 464883, 464891, 464893, 464899, 464900, 464901, 464902, 464926, 465020, 465058, 465118, 465121, 465147, 465171, 465179, 465187, 465191, 465196, 465203, 465204, 465205, 465215, 465217, 465219, 465228, 465230, 465231, 465244, 465254, 465255, 465256, 465267, 465269, 465272, 465275, 465278, 465280, 465291, 465295, 465298, 465310, 465313, 465315, 465323, 465324, 465325, 465327, 465331, 465333, 465337, 465338, 465339, 465342, 465346, 465349, 465350, 465355, 465356, 465360, 465363, 465365, 465368, 465369, 465374, 465375, 465379, 465388, 465390, 465393, 465395, 465405, 465413, 465500, 465673, 465747, 465752, 465830, 465…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0079-2026: Boston Scientific Corporation is recalling ACCOLADE SR SL (Model L300)
type: Claim
text: The FDA logged enforcement record Z-0079-2026: Boston Scientific Corporation is voluntarily recalling ACCOLADE SR SL (Model L300) — 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 00802526558900, Serial Numbers: 464190, 464192, 464197, 464228, 464229, 464230, 464238, 464258, 464279, 464295, 464296, 464316, 464321, 464358, 464360, 464361, 464362, 464363, 464369, 464371, 464378, 464383, 464384, 464392, 464393, 464398, 464400, 464406, 464408, 464409, 464410, 464411, 464414, 464425, 464427, 464430, 464432, 464435, 464437, 464441, 464442, 464443, 464451, 464455, 464456, 464466, 464469, 464474, 464480, 464484, 464485, 464487, 464488, 464489, 464496, 464502, 464503, 464504, 464507, 464520, 464529, 464531, 464534, 464538, 464544, 464547, 464551, 464556, 464558, 464560, 464566, 464571, 464577, 464583, 464585, 464586, 464587, 464588, 464591, 464592, 464604, 464608, 464611, 464617, 464623, 464635, 464637, 464639, 464642, 464643, 464653, 464660, 464662, 464664, 464665, 464667, 464668, 464681, 464683, 464685, 464692, 464697, 464698, 464699, 464700, 464706, 464707, 464708, 464712, 464715, 464720, 464721, 464726, 464730, 464734, 464736, 464738, 464740, 464741, 464743, 464744, 464745, 464746, 464749, 464750, 464751, 464754, 464758, 464761, 464766, 464767, 464771, 464772, 464774, 464775, 464776, 464778, 464779, 464781, 464784, 464787, 464788, 464795, 464796, 464797, 464800, 464805, 464806, 464807, 464810, 464811, 464821, 464824, 464825, 464828, 464830, 464831, 464833, 464837, 464838, 464843, 464848, 464852, …
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-0079-2026 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.