ACCOLADE DR SL MRI (Model L311)
type: Dataset
description: FDA recall Z-0082-2026 — Boston Scientific Corporation is recalling ACCOLADE DR SL MRI (Model L311) (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 MRI (Model L311)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0082-2026: Boston Scientific Corporation is recalling ACCOLADE DR SL MRI (Model L311)
claims: FDA classified recall Z-0082-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0082-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0082-2026
      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 00802526558962, Serial Numbers: 200737, 202944, 203132, 203273, 203512, 203621, 203903, 204448, 204712, 204767, 204877, 204938, 205006, 205007, 205020, 205029, 205055, 205063, 205068, 205069, 205076, 205077, 205079, 205088, 205116, 205218, 205226, 205261, 205328, 205330, 205339, 205354, 205355, 205375, 205398, 205400, 205423, 205457, 205515, 205544, 205552, 205601, 205613, 205633, 205642, 205645, 205651, 205656, 205668, 205694, 205699, 205705, 205713, 205716, 205717, 205719, 205728, 205772, 205778, 205808, 205816, 205818, 205830, 205833, 205835, 205838, 205870, 205896, 205956, 205983, 205995, 206085, 206094, 206117, 206123, 206144, 206152, 206157, 206252, 206260, 206265, 206285, 206325, 206375, 206404, 206408, 206411, 206505, 207204, 207462, 207887, 208016, 208046, 208192, 208212, 208325, 208368, 208372, 208379, 208434, 208449, 208461, 208465, 208471, 208489, 208632, 208636, 208651, 208658, 208690, 208788, 208952, 209027, 209089, 209115, 209132, 209185, 209198, 209201, 209214, 209215, 209221, 209230, 209231, 209253, 209338, 209365, 209443, 209820, 209837, 209851, 209873, 209888, 209893, 209918, 209924, 209931, 209990, 210009, 210010, 210015, 210059, 210092, 210107, 210120, 210150, 210157, 210160, 210182, 210202, 210255, 210300, 210345, 210348, 210354, 210434, 210469, 210513, 210517, 210846, 214405, 214877, 216563, 217673, 217871, 217939, 218076, 219080, 219100, 219169, 219194, 219243, 219266, 219308, 219327, 219338, 219375, 219384, 219451, 219457, 219479, 219523, 219689, 219710, 219712, 219720, 219725, 219732, 219759, 219768, 219769, 219775, 219805, 219806, 219809, 219811, 219825, 219840, 219853, 219857, 219867, 219878, 219880, 219883, 219887, 219909, 219911, 219916, 219926, 219933, 219938, 219952, 219963, 219975, 219981, 219984, 219986, 219987, 219992, 219995, 219998, 220003, 220005, 220020, 220022, 220025, 220034, 220035, 220036, 220044, 220052, 220064, 220067, 220079, 220080, 220081, 220118, 220162, 220175, 220177, 220185, 220224, 220343, 220347, 220349, 220…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0082-2026: Boston Scientific Corporation is recalling ACCOLADE DR SL MRI (Model L311)
type: Claim
text: The FDA logged enforcement record Z-0082-2026: Boston Scientific Corporation is voluntarily recalling ACCOLADE DR SL MRI (Model L311) — 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 00802526558962, Serial Numbers: 200737, 202944, 203132, 203273, 203512, 203621, 203903, 204448, 204712, 204767, 204877, 204938, 205006, 205007, 205020, 205029, 205055, 205063, 205068, 205069, 205076, 205077, 205079, 205088, 205116, 205218, 205226, 205261, 205328, 205330, 205339, 205354, 205355, 205375, 205398, 205400, 205423, 205457, 205515, 205544, 205552, 205601, 205613, 205633, 205642, 205645, 205651, 205656, 205668, 205694, 205699, 205705, 205713, 205716, 205717, 205719, 205728, 205772, 205778, 205808, 205816, 205818, 205830, 205833, 205835, 205838, 205870, 205896, 205956, 205983, 205995, 206085, 206094, 206117, 206123, 206144, 206152, 206157, 206252, 206260, 206265, 206285, 206325, 206375, 206404, 206408, 206411, 206505, 207204, 207462, 207887, 208016, 208046, 208192, 208212, 208325, 208368, 208372, 208379, 208434, 208449, 208461, 208465, 208471, 208489, 208632, 208636, 208651, 208658, 208690, 208788, 208952, 209027, 209089, 209115, 209132, 209185, 209198, 209201, 209214, 209215, 209221, 209230, 209231, 209253, 209338, 209365, 209443, 209820, 209837, 209851, 209873, 209888, 209893, 209918, 209924, 209931, 209990, 210009, 210010, 210015, 210059, 210092, 210107, 210120, 210150, 210157, 210160, 210182, 210202, 210255, 210300, 210345, 210348, 210354, 210434, 210469, 210513, 210517, 210846, 214405, 214877, 2165…
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-0082-2026 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.