Model Number L131, ESSENTIO DR EL MRI Pacemaker
type: Dataset
description: FDA recall Z-0097-2026 — Boston Scientific Corporation is recalling Model Number L131, ESSENTIO 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 L131, ESSENTIO DR EL MRI Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0097-2026: Boston Scientific Corporation is recalling Model Number L131, ESSENTIO DR EL MRI Pacemaker
claims: FDA classified recall Z-0097-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0097-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0097-2026
      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 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383, 102384, 102387, 102388, 102390, 102395, 102397, 102398, 102399, 102403, 102404, 102405, 102407, 102408, 102411, 102412, 102418, 102421, 102425, 102427, 102428, 102439, 102440, 102447, 102450, 102451, 102452, 102453, 102455, 102456, 102457, 102458, 102462, 102463, 102465, 102467, 102468, 102469, 102472, 102479, 102480, 102481, 102486, 102489, 102490, 102494, 102499, 102501, 102504, 102505, 102506, 102512, 102520, 102522, 102523, 102524, 102525, 102527, 102528, 102529, 102530, 102532, 102533, 102537, 102539, 102543, 102545, 102548, 102549, 102550, 102551, 102552, 102553, 102555, 102556, 102559, 102561, 102562, 102566, 102571, 102578, 102590, 102593, 102594, 102596, 102599, 102602, 102604, 102605, 102607, 102613, 102617, 102618, 102627, 102628, 102629, 102631, 102632, 102633, 102634, 110003, 110005, 110006, 110007, 110012, 110013, 110017, 110018, 110022, 110023, 110024, 110026, 110027, 110028, 110030, 110034, 110035, 110038, 110041, 110043, 110046, 110051, 110052, 110056, 110061, 110066, 110068, 110069, 110070, 110073, 110078, 110085, 110094, 110095, 110101, 110106, 110110, 110112, 110115, 110…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0097-2026: Boston Scientific Corporation is recalling Model Number L131, ESSENTIO DR EL MRI Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0097-2026: Boston Scientific Corporation is voluntarily recalling Model Number L131, ESSENTIO 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 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383, 102384, 102387, 102388, 102390, 102395, 102397, 102398, 102399, 102403, 102404, 102405, 102407, 102408, 102411, 102412, 102418, 102421, 102425, 102427, 102428, 102439, 102440, 102447, 102450, 102451, 102452, 102453, 102455, 102456, 102457, 102458, 102462, 102463, 102465, 102467, 102468, 102469, 102472, 102479, 102480, 102481, 102486, 102489, 102490, 102494, 102499, 102501, 102504, 102505, 102506, 102512, 102520, 102522, 1025…
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-0097-2026 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.