Model Number L111, ESSENTIO DR SL MRI Pacemaker
type: Dataset
description: FDA recall Z-0095-2026 — Boston Scientific Corporation is recalling Model Number L111, ESSENTIO DR 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 L111, ESSENTIO DR SL MRI Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0095-2026: Boston Scientific Corporation is recalling Model Number L111, ESSENTIO DR SL MRI Pacemaker
claims: FDA classified recall Z-0095-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0095-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0095-2026
      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 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992, 205997, 205998, 206011, 206019, 206033, 206045, 206046, 206049, 206069, 206070, 206074, 206075, 206080, 206090, 206091, 206092, 206095, 206098, 206112, 206115, 206122, 206129, 206138, 206140, 206142, 206146, 206167, 206175, 206184, 206190, 206192, 206195, 206200, 206217, 206219, 206220, 206222, 206225, 206226, 206230, 206233, 206244, 206255, 206263, 206277, 206287, 206294, 206295, 206297, 206299, 206300, 206318, 206320, 206326, 206333, 206342, 206343, 206346, 206373, 206407, 206412, 206415, 206437, 206458, 206473, 206502, 206509, 206533, 206541, 206548, 206551, 206556, 206578, 206699, 206762, 206855, 206959, 207311, 207987, 208185, 208473, 208694, 208876, 209013, 209266, 209386, 209388, 209463, 209618, 209752, 209830, 209963, 210013, 210023, 210032, 210044, 210078, 210177, 210192, 210211, 210252, 210338, 210390, 210401, 210493, 210500, 210570, 210685, 210730, 210744, 210773, 210780, 210787, 210814, 210852, 210874, 210917, 210928, 210989, 211000, 211051, 211073, 211099, 211107, 211150, 211157, 211199, 211258, 211266, 211271, 211290, 211333, 211351, 211364, 211401, 211404, 211409, 211415, 211…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0095-2026: Boston Scientific Corporation is recalling Model Number L111, ESSENTIO DR SL MRI Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0095-2026: Boston Scientific Corporation is voluntarily recalling Model Number L111, ESSENTIO DR 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 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992, 205997, 205998, 206011, 206019, 206033, 206045, 206046, 206049, 206069, 206070, 206074, 206075, 206080, 206090, 206091, 206092, 206095, 206098, 206112, 206115, 206122, 206129, 206138, 206140, 206142, 206146, 206167, 206175, 206184, 206190, 206192, 206195, 206200, 206217, 206219, 206220, 206222, 206225, 206226, 206230, 206233, 206244, 206255, 206263, 206277, 206287, 206294, 206295, 206297, 206299, 206300, 206318, 206320, 2063…
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-0095-2026 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.