Model Number L121 ESSENTIO DR EL Pacemaker
type: Dataset
description: FDA recall Z-0096-2026 — Boston Scientific Corporation is recalling Model Number L121 ESSENTIO DR EL 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 L121 ESSENTIO DR EL Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0096-2026: Boston Scientific Corporation is recalling Model Number L121 ESSENTIO DR EL Pacemaker
claims: FDA classified recall Z-0096-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0096-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0096-2026
      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 00802526559242, Serial Numbers: 100009, 100026, 100029, 100030, 100031, 100042, 100189, 100192, 100207, 100290, 100309, 100310, 100311, 100312, 100317, 100320, 100322, 100324, 100328, 100331, 100333, 100334, 100362, 100368, 100375, 100377, 100382, 100383, 100385, 100386, 100394, 100397, 100399, 100400, 100402, 100404, 100406, 100407, 100408, 100410, 100411, 100412, 100413, 100414, 100415, 100417, 100420, 100423, 100424, 100425, 100428, 100429, 100430, 100431, 100433, 100435, 100438, 100440, 100444, 100445, 100448, 100449, 100450, 100454, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100466, 100470, 100474, 100480, 100491, 100492, 100495, 100497, 100498, 100500, 100501, 100503, 100506, 100510, 100513, 100515, 100521, 100522, 100525, 100527, 100530, 100534, 100535, 100537, 100538, 100541, 100542, 100554, 100555, 100556, 100558, 100559, 100560, 100561, 100562, 100563, 100567, 100570, 100571, 100582, 100590, 100594, 100596, 100599, 100604, 100605, 100606, 100607, 100608, 100613, 100617, 100618, 100620, 100622, 100625, 100626, 100628, 100629, 100631, 100632, 100633, 100634, 100635, 100636, 100637, 100638, 100639, 100641, 100643, 100644, 100645, 100646, 100647, 100648, 100649, 100650, 100651, 100653, 100656, 100657, 100658, 100659, 100660, 100661, 100666, 100668, 100669, 100670, 100671, 100672, 100673, 100676, 100677, 100681, 100682, 100684, 100685, 100686, 100688, 100693, 100694, 100695, 100697, 100698, 100699, 100700, 100703, 100705, 100709, 100710, 100712, 100713, 100715, 100716, 100717, 100718, 100719, 100720, 100721, 100723, 100725, 100726, 100727, 100728, 100730, 100731, 100732, 100735, 100739, 100742, 100746, 100747, 100749, 100750, 100754, 100759, 100763, 100767, 100768, 100769, 100773, 100775, 100776, 100778, 100779, 100783, 100784, 100785, 100786, 100787, 100793, 100794, 100795, 100799, 100808, 100813, 100817, 100823, 100825, 100826, 100827, 100830, 100833, 100842, 100843, 100845, 100846, 100853, 100855, 100860, 100862, 100863, 100864, 100…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0096-2026: Boston Scientific Corporation is recalling Model Number L121 ESSENTIO DR EL Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0096-2026: Boston Scientific Corporation is voluntarily recalling Model Number L121 ESSENTIO DR EL 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 00802526559242, Serial Numbers: 100009, 100026, 100029, 100030, 100031, 100042, 100189, 100192, 100207, 100290, 100309, 100310, 100311, 100312, 100317, 100320, 100322, 100324, 100328, 100331, 100333, 100334, 100362, 100368, 100375, 100377, 100382, 100383, 100385, 100386, 100394, 100397, 100399, 100400, 100402, 100404, 100406, 100407, 100408, 100410, 100411, 100412, 100413, 100414, 100415, 100417, 100420, 100423, 100424, 100425, 100428, 100429, 100430, 100431, 100433, 100435, 100438, 100440, 100444, 100445, 100448, 100449, 100450, 100454, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100466, 100470, 100474, 100480, 100491, 100492, 100495, 100497, 100498, 100500, 100501, 100503, 100506, 100510, 100513, 100515, 100521, 100522, 100525, 100527, 100530, 100534, 100535, 100537, 100538, 100541, 100542, 100554, 100555, 100556, 100558, 100559, 100560, 100561, 100562, 100563, 100567, 100570, 100571, 100582, 100590, 100594, 100596, 100599, 100604, 100605, 100606, 100607, 100608, 100613, 100617, 100618, 100620, 100622, 100625, 100626, 100628, 100629, 100631, 100632, 100633, 100634, 100635, 100636, 100637, 100638, 100639, 100641, 100643, 100644, 100645, 100646, 100647, 100648, 100649, 100650, 100651, 100653, 100656, 100657, 100658, 100659, 100660, 100661, 100666, 100668, 100669, 100670, 100671, 1…
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-0096-2026 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.