Model Number L110, ESSENTIO SR SL MRI Pacemaker
type: Dataset
description: FDA recall Z-0094-2026 — Boston Scientific Corporation is recalling Model Number L110, ESSENTIO SR SL 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 L110, ESSENTIO SR SL MRI Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0094-2026: Boston Scientific Corporation is recalling Model Number L110, ESSENTIO SR SL MRI Pacemaker
claims: FDA classified recall Z-0094-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0094-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0094-2026
      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 00802526559204, Serial Numbers: 102163, 700197, 700207, 701035, 701546, 702086, 702129, 702195, 702303, 702316, 702343, 702530, 702612, 702615, 702619, 702715, 702745, 702802, 702807, 702833, 702840, 702844, 702871, 702872, 702890, 702891, 702898, 702912, 702918, 702925, 702930, 702931, 702966, 702974, 702979, 702991, 702999, 703010, 703035, 703047, 703053, 703058, 703065, 703069, 703090, 703099, 703101, 703122, 703124, 703136, 703142, 703147, 703150, 703152, 703173, 703177, 703191, 703199, 703240, 703241, 703247, 703252, 703261, 703297, 703306, 703326, 703339, 703348, 703353, 703376, 703380, 703417, 703420, 703450, 703452, 703453, 703460, 703510, 703511, 703535, 704093, 704200, 704263, 704341, 704480, 704580, 704656, 704661, 704678, 704679, 704703, 704726, 704755, 704769, 704802, 704812, 704813, 704815, 704817, 704820, 704823, 704839, 704849, 704869, 704872, 704875, 704895, 704898, 704900, 704915, 704926, 704938, 704945, 704956, 704986, 704998, 705007, 705010, 705020, 705038, 705054, 705119, 705200, 705372, 705557, 705934, 705951, 705974, 705989, 706005, 706129, 706340, 706579, 707685, 707751, 707758, 708308, 708404, 708490, 708804, 709351, 709443, 709847, 710013, 710082, 710117, 710287, 710329, 710336, 710378, 710403, 710463, 710478, 710565, 710567, 710607, 710608, 710612, 710623, 710655, 710687, 710697, 710720, 710729, 710731, 710748, 710749, 710750, 710752, 710761, 710763, 710768, 710821, 710870, 710877, 710878, 710884, 710889, 710890, 710898, 710901, 711141, 711142, 711143, 711147, 711154, 711155, 711157, 711158, 711159, 711179, 711181, 711183, 711185, 711188, 711189, 711190, 711192, 711194, 711195, 711198, 711199, 711200, 711201, 711203, 711206, 711209, 711213, 711214, 711215, 711218, 711219, 711230, 711234, 711241, 711242, 711245, 711246, 711247, 711248, 711252, 711256, 711257, 711261, 711267, 711272, 711276, 711278, 711288, 711291, 711296, 711300, 711301, 711303, 711318, 711319, 711322, 711327, 711331, 711337, 711338, 711340, 711344, 711353, 711361, 711…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0094-2026: Boston Scientific Corporation is recalling Model Number L110, ESSENTIO SR SL MRI Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0094-2026: Boston Scientific Corporation is voluntarily recalling Model Number L110, ESSENTIO SR SL 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 00802526559204, Serial Numbers: 102163, 700197, 700207, 701035, 701546, 702086, 702129, 702195, 702303, 702316, 702343, 702530, 702612, 702615, 702619, 702715, 702745, 702802, 702807, 702833, 702840, 702844, 702871, 702872, 702890, 702891, 702898, 702912, 702918, 702925, 702930, 702931, 702966, 702974, 702979, 702991, 702999, 703010, 703035, 703047, 703053, 703058, 703065, 703069, 703090, 703099, 703101, 703122, 703124, 703136, 703142, 703147, 703150, 703152, 703173, 703177, 703191, 703199, 703240, 703241, 703247, 703252, 703261, 703297, 703306, 703326, 703339, 703348, 703353, 703376, 703380, 703417, 703420, 703450, 703452, 703453, 703460, 703510, 703511, 703535, 704093, 704200, 704263, 704341, 704480, 704580, 704656, 704661, 704678, 704679, 704703, 704726, 704755, 704769, 704802, 704812, 704813, 704815, 704817, 704820, 704823, 704839, 704849, 704869, 704872, 704875, 704895, 704898, 704900, 704915, 704926, 704938, 704945, 704956, 704986, 704998, 705007, 705010, 705020, 705038, 705054, 705119, 705200, 705372, 705557, 705934, 705951, 705974, 705989, 706005, 706129, 706340, 706579, 707685, 707751, 707758, 708308, 708404, 708490, 708804, 709351, 709443, 709847, 710013, 710082, 710117, 710287, 710329, 710336, 710378, 710403, 710463, 710478, 710565, 710567, 710607, 710608, 710612, 710623, 710655, 7106…
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-0094-2026 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.