Model Number U225 VISIONIST CRT-P EL
type: Dataset
description: FDA recall Z-0103-2026 — Boston Scientific Corporation is recalling Model Number U225 VISIONIST CRT-P EL (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 U225 VISIONIST CRT-P EL
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0103-2026: Boston Scientific Corporation is recalling Model Number U225 VISIONIST CRT-P EL
claims: FDA classified recall Z-0103-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0103-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0103-2026
      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 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912, 709914, 709926, 709935, 709938, 709941, 709943, 709962, 709965, 709966, 709969, 709985, 710005, 710016, 710027, 710105, 710235, 710283, 710379, 710386, 710408, 710414, 710416, 710418, 710424, 710438, 710443, 710450, 710458, 710459, 710466, 710467, 710479, 710481, 710482, 710490, 710540, 710544, 710545, 710558, 710561, 710566, 710571, 710572, 710575, 710586, 710593, 710595, 710600, 710613, 710622, 710624, 711100, 711103, 711115, 711116, 711186, 711234, 711261, 711493, 711497, 711646, 711698, 711699, 711704, 711706, 711719, 711756, 711771, 711780, 711781, 711783, 711784, 711812, 711817, 711852, 711859, 711865, 711867, 711870, 711881, 711894, 711896, 711901, 711913, 711915, 711916, 711927, 711929, 711933, 711941, 711977, 711984, 712029, 712100, 712114, 712120, 712122, 712140, 712143, 712187, 712188, 712192, 712194, 712196, 712197, 712205, 712211, 712269, 712275, 712302, 712361, 712362, 712368, 712394, 712395, 712446, 712452, 712454, 712467, 712468, 712472, 712475, 712485, 712487, 712518, 712562, 712570, 712605, 712647, 712660, 712665, 712668, 712669, 712676, 712684, 712716, 712730, 712732, 712734, 712740, 712743, 712749, 712763, 712791, 712837, 712843, 712908, 712936, 712971, 713013, 713125, 713135, 713155, 713157, 713158, 713161, 713176, 713179, 713184, 713185, 713199, 713201, 713206, 713212, 713216, 713229, 713231, 713232, 713237, 713243, 713247, 713250, 713261, 713265, 713269, 713270, 713272, 713275, 713278, 713281, 713286, 713287, 713289, 713290, 713291, 713297, 713298, 713299, 713305, 713306, 713307, 713308, 713313, 713314, 713316, 713317, 713318, 713324, 713332, 713375, 713401, 714487, 714533, 714580, 714630, 714634, 714689, 714690, 714693, 714695, 714730, 714731, 714732, 714733, 714734, 714735, 714737, 714749, 714755, 714757, 714829, 714831, 714836, 714837, 714851, 714852, 714…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0103-2026: Boston Scientific Corporation is recalling Model Number U225 VISIONIST CRT-P EL
type: Claim
text: The FDA logged enforcement record Z-0103-2026: Boston Scientific Corporation is voluntarily recalling Model Number U225 VISIONIST CRT-P EL — 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 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912, 709914, 709926, 709935, 709938, 709941, 709943, 709962, 709965, 709966, 709969, 709985, 710005, 710016, 710027, 710105, 710235, 710283, 710379, 710386, 710408, 710414, 710416, 710418, 710424, 710438, 710443, 710450, 710458, 710459, 710466, 710467, 710479, 710481, 710482, 710490, 710540, 710544, 710545, 710558, 710561, 710566, 710571, 710572, 710575, 710586, 710593, 710595, 710600, 710613, 710622, 710624, 711100, 711103, 711115, 711116, 711186, 711234, 711261, 711493, 711497, 711646, 711698, 711699, 711704, 711706, 711719, 711756, 711771, 711780, 711781, 711783, 711784, 711812, 711817, 711852, 711859, 711865, 711867, 711870, 711881, 711894, 711896, 711901, 711913, 711915, 711916, 711927, 711929, 711933, 711941, 711977, 711984, 712029, 712100, 712114, 712120, 712122, 712140, 712143, 712187, 712188, 712192, 712194, 712196, 712197, 712205, 712211, 712269, 712275, 712302, 712361, 712362, 712368, 712394, 712395, 712446, 712452, 712454, 712467, 712468, 712472, 712475, 712485, 712487, 712518, 712562, 712570, 712605, 712647, 712660, 712665, 712668, 712669, 712676, 712684, 712716, 712730, 712732, 712734, 712740, 712743, 712749, 712763,…
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-0103-2026 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.