Model Number L231, PROPONENT DR EL MRI Pacemaker
type: Dataset
description: FDA recall Z-0091-2026 — Boston Scientific Corporation is recalling Model Number L231, PROPONENT DR EL MRI Pacemaker (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: Model Number L231, PROPONENT DR EL MRI Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0091-2026: Boston Scientific Corporation is recalling Model Number L231, PROPONENT DR EL MRI Pacemaker
claims: FDA classified recall Z-0091-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0091-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0091-2026
      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 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 973836. GTIN 00802526578052, Serial Numbers: 594082, 727921, 812172, 832267, 899037, 944246, 978524. GTIN 00802526559143, Serial Numbers: 100008, 100026, 100030, 100038, 100045, 100046, 100052, 100053, 100059, 100061, 100066, 100077, 100078, 100079, 100081, 100083, 100087, 100088, 100099, 100104, 100105, 100108, 100114, 100126, 100130, 100134, 100136, 100142, 100148, 100151, 100153, 100154, 100156, 100161, 100162, 100163, 100164, 100165, 100168, 100172, 100175, 100178, 100180, 100181, 100187, 100188, 100190, 100191, 100193, 100196, 100199, 100201, 100203, 100205, 100206, 100207, 100208, 100210, 100212, 100213, 100216, 100218, 100220, 100235, 100236, 100243, 100244, 100245, 100246, 100247, 100251, 100252, 100253, 100254, 100256, 100261, 100265, 100275, 100279, 100280, 100282, 100283, 100288, 100289, 100292, 100293, 100294, 100296, 100299, 100300, 100302, 100305, 100306, 100307, 100308, 100309, 100310, 100314, 100316, 100317, 100318, 100322, 100326, 100327, 100328, 100329, 100333, 100335, 100339, 100340, 100341, 100342, 100345, 100348, 100350, 100352, 100358, 100361, 100364, 100365, 100366, 100367, 100368, 100370, 100371, 100372, 100373, 100375, 100376, 100377, 100379, 100381, 100389, 100395, 100409, 100411, 100412, 100414, 100415, 100416, 100417, 100418, 100438, 100439, 100441, 100442, 100443, 100444, 100445, 100447, 100448, 100449, 100450, 100451, 100452, 100454, 100455, 100456, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100479, 100480, 100481, 100482, 100483, 100484, 100488, 100491, 100494, 100497, 100507, 100516, 100517, 100518, 100519, 100523, 100529, 100531, 100532, 100541, 100543, 100554, 100555, 100558, 100560, 100566, 100586, 100588, 100589, 100595, 100596, 100598, 100609, 100610, 100613, 100614, 100623, 100624, 100625, 100627, 100628, 1006…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0091-2026: Boston Scientific Corporation is recalling Model Number L231, PROPONENT DR EL MRI Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0091-2026: Boston Scientific Corporation is voluntarily recalling Model Number L231, PROPONENT DR EL MRI Pacemaker — 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 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 973836. GTIN 00802526578052, Serial Numbers: 594082, 727921, 812172, 832267, 899037, 944246, 978524. GTIN 00802526559143, Serial Numbers: 100008, 100026, 100030, 100038, 100045, 100046, 100052, 100053, 100059, 100061, 100066, 100077, 100078, 100079, 100081, 100083, 100087, 100088, 100099, 100104, 100105, 100108, 100114, 100126, 100130, 100134, 100136, 100142, 100148, 100151, 100153, 100154, 100156, 100161, 100162, 100163, 100164, 100165, 100168, 100172, 100175, 100178, 100180, 100181, 100187, 100188, 100190, 100191, 100193, 100196, 100199, 100201, 100203, 100205, 100206, 100207, 100208, 100210, 100212, 100213, 100216, 100218, 100220, 100235, 100236, 100243, 100244, 100245, 100246, 100247, 100251, 100252, 100253, 100254, 100256, 100261, 100265, 100275, 100279, 100280, 100282, 100283, 100288, 100289, 100292, 100293, 100294, 100296, 100299, 100300, 100302, 100305, 100306, 100307, 100308, 100309, 100310, 100314, 100316, 100317, 100318, 100322, 100326, 100327, 100328, 100329, 100333, 100335, 100339, 100340, 100341, 100342, 100345, 100348, 100350, 100352, 100358, 100361, 100364, 100365, 100366, 100367, 100368, 100370, 100371, 100372, 100373, 100375, 100376, 100377, 100379, 100381, 100389, 1003…
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-0091-2026 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.