ACCOLADE DR SL (Model L301)
type: Dataset
description: FDA recall Z-0080-2026 — Boston Scientific Corporation is recalling ACCOLADE DR SL (Model L301) (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 DR SL (Model L301)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0080-2026: Boston Scientific Corporation is recalling ACCOLADE DR SL (Model L301)
claims: FDA classified recall Z-0080-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0080-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0080-2026
      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 00802526558924, Serial Numbers: 100056, 100092, 100111, 100120, 100122, 100125, 100127, 100134, 100136, 100137, 100142, 100144, 100147, 100154, 100156, 100160, 100161, 100162, 100168, 100177, 100179, 100183, 100184, 100185, 100190, 100192, 100200, 100206, 100207, 100214, 100217, 100224, 100226, 100227, 100230, 100231, 100234, 100235, 100236, 100237, 100238, 100246, 100253, 100255, 100258, 100261, 100268, 100269, 100277, 100279, 100284, 100285, 100288, 100291, 100293, 100299, 100302, 100303, 100304, 100307, 100313, 100316, 100323, 100326, 100334, 100337, 100341, 100342, 100344, 100345, 100353, 100355, 100356, 100359, 100366, 100368, 100373, 100374, 100377, 100388, 100389, 100391, 100394, 100396, 100399, 100402, 100411, 100419, 100421, 100426, 100428, 100429, 100437, 100440, 100441, 100445, 100447, 100448, 100449, 100450, 100454, 100456, 100457, 100460, 100467, 100468, 100469, 100472, 100474, 100475, 100491, 100493, 100497, 100498, 100499, 100501, 100502, 100503, 100505, 100507, 100509, 100510, 100511, 100520, 100521, 100530, 100532, 100542, 100543, 100548, 100552, 100557, 100560, 100562, 100565, 100568, 100569, 100571, 100572, 100573, 100587, 100597, 100610, 100611, 100613, 100617, 100622, 100627, 100629, 100630, 100641, 100653, 100665, 100666, 100667, 100668, 100669, 100671, 100673, 100675, 100677, 100681, 100682, 100683, 100687, 100690, 100691, 100692, 100696, 100697, 100701, 100702, 100703, 100705, 100706, 100710, 100716, 100717, 100718, 100719, 100723, 100724, 100726, 100727, 100735, 100740, 100741, 100745, 100755, 100760, 100761, 100762, 100774, 100778, 100792, 100820, 100823, 100830, 100831, 100851, 100860, 100862, 101029, 101051, 101054, 101079, 101100, 101117, 101119, 101123, 101167, 101217, 101277, 101280, 101291, 101295, 101333, 101352, 101364, 101367, 101370, 101376, 101377, 101385, 101392, 101404, 101408, 101425, 101428, 101441, 101480, 101498, 101499, 101512, 101558, 101566, 101570, 101578, 101595, 101624, 101673, 101680, 101683, 101694, 101716, 101…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0080-2026: Boston Scientific Corporation is recalling ACCOLADE DR SL (Model L301)
type: Claim
text: The FDA logged enforcement record Z-0080-2026: Boston Scientific Corporation is voluntarily recalling ACCOLADE DR SL (Model L301) — 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 00802526558924, Serial Numbers: 100056, 100092, 100111, 100120, 100122, 100125, 100127, 100134, 100136, 100137, 100142, 100144, 100147, 100154, 100156, 100160, 100161, 100162, 100168, 100177, 100179, 100183, 100184, 100185, 100190, 100192, 100200, 100206, 100207, 100214, 100217, 100224, 100226, 100227, 100230, 100231, 100234, 100235, 100236, 100237, 100238, 100246, 100253, 100255, 100258, 100261, 100268, 100269, 100277, 100279, 100284, 100285, 100288, 100291, 100293, 100299, 100302, 100303, 100304, 100307, 100313, 100316, 100323, 100326, 100334, 100337, 100341, 100342, 100344, 100345, 100353, 100355, 100356, 100359, 100366, 100368, 100373, 100374, 100377, 100388, 100389, 100391, 100394, 100396, 100399, 100402, 100411, 100419, 100421, 100426, 100428, 100429, 100437, 100440, 100441, 100445, 100447, 100448, 100449, 100450, 100454, 100456, 100457, 100460, 100467, 100468, 100469, 100472, 100474, 100475, 100491, 100493, 100497, 100498, 100499, 100501, 100502, 100503, 100505, 100507, 100509, 100510, 100511, 100520, 100521, 100530, 100532, 100542, 100543, 100548, 100552, 100557, 100560, 100562, 100565, 100568, 100569, 100571, 100572, 100573, 100587, 100597, 100610, 100611, 100613, 100617, 100622, 100627, 100629, 100630, 100641, 100653, 100665, 100666, 100667, 100668, 100669, 100671, 100673, 100675, 100677, 100681, 100682, …
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-0080-2026 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.