ACCOLADE DR EL MRI (Model L331)
type: Dataset
description: FDA recall Z-0084-2026 — Boston Scientific Corporation is recalling ACCOLADE DR EL MRI (Model L331) (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 EL MRI (Model L331)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0084-2026: Boston Scientific Corporation is recalling ACCOLADE DR EL MRI (Model L331)
claims: FDA classified recall Z-0084-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0084-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0084-2026
      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 00802526559006, Serial Numbers: 102138, 102172, 102192, 102209, 102210, 102229, 102231, 102232, 102233, 102237, 102239, 102243, 102255, 102256, 102261, 102263, 102265, 102266, 102267, 102269, 102273, 102274, 102277, 102290, 102358, 102389, 102392, 102422, 102435, 102438, 102441, 102445, 102448, 102460, 102464, 102466, 102474, 102503, 102513, 102564, 102624, 102625, 110031, 110032, 110057, 110099, 110165, 110168, 110174, 110176, 110261, 110262, 110280, 110293, 110318, 110371, 110433, 110436, 110496, 110507, 110517, 110550, 110718, 110749, 110768, 110814, 110837, 110841, 110846, 110865, 110876, 110932, 110933, 110938, 110939, 110953, 110965, 110984, 110985, 110989, 111044, 111074, 111095, 111104, 111116, 111143, 111160, 111171, 111172, 111174, 111184, 111186, 111228, 111241, 111245, 111254, 111272, 111331, 111332, 111339, 111340, 111341, 111342, 111344, 111367, 111375, 111383, 111398, 111399, 111405, 111410, 111411, 111427, 111484, 111497, 111499, 111500, 111502, 111503, 111504, 111508, 111509, 111512, 111514, 111516, 111518, 111520, 111522, 111535, 111536, 111538, 111550, 111552, 111557, 111561, 111575, 111586, 111590, 111591, 111593, 111606, 111611, 111612, 111614, 111615, 111676, 111678, 111701, 111708, 112011, 112235, 112407, 112682, 112771, 112776, 112778, 112825, 112839, 112915, 112919, 113046, 113067, 113068, 113097, 113103, 113121, 113128, 113159, 113207, 113216, 113230, 113267, 113270, 113271, 113284, 113294, 113300, 113304, 113354, 113401, 113410, 113455, 113488, 113541, 113552, 113557, 113589, 113590, 113621, 113658, 113712, 113722, 113723, 113809, 113818, 113823, 530017, 530020, 530021, 530024, 530032, 530048, 530094, 530163, 530168, 530169, 530173, 530174, 530178, 530179, 530234, 530237, 530242, 530245, 530248, 530266, 530267, 530270, 530274, 530279, 530280, 530303, 530338, 530341, 530358, 530391, 530396, 530403, 530406, 530433, 530435, 530436, 530437, 530466, 530468, 530541, 530545, 530546, 530547, 530550, 530551, 530554, 530558, 530609, 530763, 530…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0084-2026: Boston Scientific Corporation is recalling ACCOLADE DR EL MRI (Model L331)
type: Claim
text: The FDA logged enforcement record Z-0084-2026: Boston Scientific Corporation is voluntarily recalling ACCOLADE DR EL MRI (Model L331) — 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 00802526559006, Serial Numbers: 102138, 102172, 102192, 102209, 102210, 102229, 102231, 102232, 102233, 102237, 102239, 102243, 102255, 102256, 102261, 102263, 102265, 102266, 102267, 102269, 102273, 102274, 102277, 102290, 102358, 102389, 102392, 102422, 102435, 102438, 102441, 102445, 102448, 102460, 102464, 102466, 102474, 102503, 102513, 102564, 102624, 102625, 110031, 110032, 110057, 110099, 110165, 110168, 110174, 110176, 110261, 110262, 110280, 110293, 110318, 110371, 110433, 110436, 110496, 110507, 110517, 110550, 110718, 110749, 110768, 110814, 110837, 110841, 110846, 110865, 110876, 110932, 110933, 110938, 110939, 110953, 110965, 110984, 110985, 110989, 111044, 111074, 111095, 111104, 111116, 111143, 111160, 111171, 111172, 111174, 111184, 111186, 111228, 111241, 111245, 111254, 111272, 111331, 111332, 111339, 111340, 111341, 111342, 111344, 111367, 111375, 111383, 111398, 111399, 111405, 111410, 111411, 111427, 111484, 111497, 111499, 111500, 111502, 111503, 111504, 111508, 111509, 111512, 111514, 111516, 111518, 111520, 111522, 111535, 111536, 111538, 111550, 111552, 111557, 111561, 111575, 111586, 111590, 111591, 111593, 111606, 111611, 111612, 111614, 111615, 111676, 111678, 111701, 111708, 112011, 112235, 112407, 112682, 112771, 112776, 112778, 112825, 112839, 112915, 112919, 113046, 113067, 1130…
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-0084-2026 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.