Model Number U228, VISIONIST CRT-P EL MRI
type: Dataset
description: FDA recall Z-0105-2026 — Boston Scientific Corporation is recalling Model Number U228, VISIONIST CRT-P EL MRI (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 U228, VISIONIST CRT-P EL MRI
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0105-2026: Boston Scientific Corporation is recalling Model Number U228, VISIONIST CRT-P EL MRI
claims: FDA classified recall Z-0105-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0105-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0105-2026
      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 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748, 733749, 733755, 733756, 733773, 733776, 733778, 733791, 733792, 733794, 733797, 733799, 733800, 733801, 733804, 733805, 733807, 733808, 733811, 733812, 733815, 733818, 733819, 733820, 733824, 733829, 733830, 733832, 733833, 733834, 733841, 733842, 733843, 733846, 733851, 733852, 733853, 733854, 733859, 733861, 733862, 733864, 733876, 733880, 733881, 733883, 733887, 733888, 733895, 733896, 733897, 733898, 733899, 733904, 733907, 733908, 733909, 733916, 733925, 733926, 733927, 733928, 733931, 733934, 733935, 733936, 733939, 733944, 733960, 733976, 733980, 733982, 734809, 734811, 734812, 734822, 734824, 734837, 734844, 734870, 734880, 734884, 734899, 734902, 734939, 734944, 734955, 734960, 734967, 734977, 734982, 734991, 734992, 734997, 734998, 734999, 735005, 735006, 735013, 735015, 735024, 735028, 735034, 735035, 735039, 735042, 735045, 735053, 735056, 735061, 735067, 735070, 735075, 735083, 735088, 735127, 735217, 735250, 735251, 735262, 735328, 735333, 735340, 735341, 735351, 735401, 735412, 735434, 735440, 735446, 735447, 735455, 735478, 735481, 735494, 735498, 735505, 735506, 735508, 735510, 735511, 735512, 735514, 735515, 735516, 735520, 735525, 735527, 735531, 735532, 735539, 735546, 735547, 735561, 735562, 735575, 735582, 735585, 735591, 735611, 735625, 735635, 735643, 735667, 735756, 735764, 735770, 735775, 735786, 735789, 735800, 735801, 735804, 735817, 735819, 735830, 735833, 735836, 735856, 735859, 735863, 735865, 735872, 735873, 735896, 735898, 735900, 735901, 735905, 735909, 735911, 735915, 735925, 735927, 735928, 735933, 735935, 735939, 735942, 735943, 735966, 735976, 735979, 735995, 735997, 736003, 736004, 736010, 736013, 736064, 737424, 737687, 737884, 737890, 737900, 738094, 738096, 738106, 738157, 738186, 738191, 738235, 738237, 738246, 738248, 738258, 738263, 738…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0105-2026: Boston Scientific Corporation is recalling Model Number U228, VISIONIST CRT-P EL MRI
type: Claim
text: The FDA logged enforcement record Z-0105-2026: Boston Scientific Corporation is voluntarily recalling Model Number U228, VISIONIST CRT-P EL MRI — 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 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748, 733749, 733755, 733756, 733773, 733776, 733778, 733791, 733792, 733794, 733797, 733799, 733800, 733801, 733804, 733805, 733807, 733808, 733811, 733812, 733815, 733818, 733819, 733820, 733824, 733829, 733830, 733832, 733833, 733834, 733841, 733842, 733843, 733846, 733851, 733852, 733853, 733854, 733859, 733861, 733862, 733864, 733876, 733880, 733881, 733883, 733887, 733888, 733895, 733896, 733897, 733898, 733899, 733904, 733907, 733908, 733909, 733916, 733925, 733926, 733927, 733928, 733931, 733934, 733935, 733936, 733939, 733944, 733960, 733976, 733980, 733982, 734809, 734811, 734812, 734822, 734824, 734837, 734844, 734870, 734880, 734884, 734899, 734902, 734939, 734944, 734955, 734960, 734967, 734977, 734982, 734991, 734992, 734997, 734998, 734999, 735005, 735006, 735013, 735015, 735024, 735028, 735034, 735035, 735039, 735042, 735045, 735053, 735056, 735061, 735067, 735070, 735075, 735083, 735088, 735127, 735217, 735250, 735251, 735262, 735328, 735333, 735340, 735341, 735351, 735401, 735412, 735434, 735440, 735446, 735447, 735455, 735478, 735481, 735494, 735498, 735505, 735506, 735508, 735510, 735511, 735512, 735514, 73…
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-0105-2026 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.