ACCOLADE SR SL MRI (Model L310)
type: Dataset
description: FDA recall Z-0081-2026 — Boston Scientific Corporation is recalling ACCOLADE SR SL MRI (Model L310) (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 MRI (Model L310)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0081-2026: Boston Scientific Corporation is recalling ACCOLADE SR SL MRI (Model L310)
claims: FDA classified recall Z-0081-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0081-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0081-2026
      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 00802526558948, Serial Numbers: 701140, 701954, 702152, 702176, 702278, 702560, 702997, 702998, 703023, 703075, 703125, 703128, 703138, 703169, 703172, 703201, 703203, 703251, 703253, 703272, 703307, 703324, 703331, 703343, 703395, 703427, 703447, 703451, 703458, 703504, 703508, 703534, 703538, 703546, 703547, 703628, 703656, 703754, 703790, 703839, 704235, 704285, 704300, 704307, 704351, 704493, 704495, 704563, 704590, 704877, 705061, 705070, 705078, 705085, 705105, 705130, 705163, 705169, 705192, 705196, 705225, 705253, 705261, 705270, 705443, 705446, 705523, 705526, 705529, 705541, 705545, 705546, 705573, 705579, 705584, 705587, 705593, 705612, 706491, 707091, 707196, 707376, 707777, 708269, 708354, 709408, 709434, 709521, 709549, 709575, 709578, 709659, 709678, 709687, 709710, 709744, 709750, 709773, 709794, 709813, 709824, 709844, 709862, 709905, 709918, 709930, 709945, 709949, 709950, 709962, 709972, 709986, 710005, 710006, 710014, 710027, 710035, 710036, 710046, 710047, 710061, 710062, 710072, 710075, 710102, 710105, 710139, 710148, 710151, 710174, 710176, 710207, 710276, 710332, 710354, 710413, 710421, 710423, 710446, 710468, 710472, 710474, 710485, 710487, 710492, 710500, 710509, 710511, 710512, 710524, 710527, 710529, 710545, 710549, 710550, 710592, 710594, 710597, 710626, 710644, 710692, 710698, 710711, 710727, 710765, 710873, 710875, 710876, 710879, 710885, 710893, 710899, 710900, 710910, 710912, 710914, 711138, 711139, 711140, 711148, 711163, 711164, 711166, 711174, 711180, 711208, 711210, 711223, 711229, 711259, 711263, 711264, 711275, 711289, 711314, 711335, 711343, 711346, 711348, 711349, 711389, 711527, 711529, 711535, 711544, 711553, 711564, 711571, 711577, 711580, 711585, 711602, 711605, 711611, 711622, 711628, 711632, 711634, 711654, 711679, 711685, 711691, 711692, 711694, 711698, 711708, 711715, 711730, 711731, 711741, 711751, 711752, 711756, 711767, 711771, 711777, 711784, 711785, 711809, 711812, 711813, 711817, 711828, 711835, 711837, 711…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0081-2026: Boston Scientific Corporation is recalling ACCOLADE SR SL MRI (Model L310)
type: Claim
text: The FDA logged enforcement record Z-0081-2026: Boston Scientific Corporation is voluntarily recalling ACCOLADE SR SL MRI (Model L310) — 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 00802526558948, Serial Numbers: 701140, 701954, 702152, 702176, 702278, 702560, 702997, 702998, 703023, 703075, 703125, 703128, 703138, 703169, 703172, 703201, 703203, 703251, 703253, 703272, 703307, 703324, 703331, 703343, 703395, 703427, 703447, 703451, 703458, 703504, 703508, 703534, 703538, 703546, 703547, 703628, 703656, 703754, 703790, 703839, 704235, 704285, 704300, 704307, 704351, 704493, 704495, 704563, 704590, 704877, 705061, 705070, 705078, 705085, 705105, 705130, 705163, 705169, 705192, 705196, 705225, 705253, 705261, 705270, 705443, 705446, 705523, 705526, 705529, 705541, 705545, 705546, 705573, 705579, 705584, 705587, 705593, 705612, 706491, 707091, 707196, 707376, 707777, 708269, 708354, 709408, 709434, 709521, 709549, 709575, 709578, 709659, 709678, 709687, 709710, 709744, 709750, 709773, 709794, 709813, 709824, 709844, 709862, 709905, 709918, 709930, 709945, 709949, 709950, 709962, 709972, 709986, 710005, 710006, 710014, 710027, 710035, 710036, 710046, 710047, 710061, 710062, 710072, 710075, 710102, 710105, 710139, 710148, 710151, 710174, 710176, 710207, 710276, 710332, 710354, 710413, 710421, 710423, 710446, 710468, 710472, 710474, 710485, 710487, 710492, 710500, 710509, 710511, 710512, 710524, 710527, 710529, 710545, 710549, 710550, 710592, 710594, 710597, 710626, 710644, 710692, 710698, 7107…
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-0081-2026 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.