Model Number U125, VALITUDE CRT-P EL
type: Dataset
description: FDA recall Z-0101-2026 — Boston Scientific Corporation is recalling Model Number U125, VALITUDE 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 U125, VALITUDE CRT-P EL
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0101-2026: Boston Scientific Corporation is recalling Model Number U125, VALITUDE CRT-P EL
claims: FDA classified recall Z-0101-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0101-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0101-2026
      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 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 100258, 100259, 100263, 100270, 100285, 100287, 100292, 100298, 100301, 100302, 100307, 100310, 100315, 100323, 100331, 100333, 100339, 100342, 100343, 100348, 100349, 100350, 100357, 100358, 100359, 100360, 100362, 100366, 100367, 100371, 100372, 100375, 100378, 100386, 100390, 100392, 100394, 100396, 100397, 100401, 100402, 100403, 100406, 100409, 100412, 100413, 100418, 100419, 100420, 100423, 100429, 100430, 100432, 100435, 100438, 100448, 100452, 100453, 100455, 100456, 100458, 100462, 100466, 100467, 100472, 100473, 100475, 100476, 100480, 100481, 100482, 100485, 100486, 100489, 100492, 100493, 100495, 100496, 100497, 100498, 100499, 100500, 100502, 100505, 100510, 100514, 100518, 100526, 100529, 100532, 100533, 100536, 100537, 100539, 100540, 100541, 100544, 100546, 100548, 100549, 100552, 100560, 100566, 100570, 100572, 100573, 100575, 100576, 100578, 100582, 100583, 100585, 100591, 100593, 100598, 100603, 100605, 100612, 100614, 100618, 100625, 100626, 100632, 100635, 100636, 100640, 100642, 100643, 100645, 100646, 100647, 100648, 100650, 100653, 100657, 100658, 100661, 100666, 100671, 100672, 100674, 100676, 100679, 100683, 100684, 100687, 100690, 100692, 100693, 100697, 100699, 100700, 100703, 100707, 100711, 100713, 100721, 100722, 100723, 100725, 100726, 100730, 100731, 100735, 100740, 100743, 100746, 100751, 100754, 100755, 100756, 100757, 100758, 100759, 100760, 100761, 100763, 100767, 100770, 100772, 100774, 100775, 100776, 100777, 100778, 100779, 100780, 100781, 100784, 100786, 100788, 100789, 100790, 100792, 100799, 100802, 100803, 100805, 100813, 100814, 100823, 100830, 100833, 100846, 100864, 100866, 100870, 100871, 100873, 100886, 100891, 100893, 100910, 700191, 700207, 700250, 700252, 700272, 700306, 700507, 700582, 700630, 700713, 700726, 700735, 700762, 700796, 700801, 700802, 700820, 700832, 700834, 700837, 700839, 700852, 700…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0101-2026: Boston Scientific Corporation is recalling Model Number U125, VALITUDE CRT-P EL
type: Claim
text: The FDA logged enforcement record Z-0101-2026: Boston Scientific Corporation is voluntarily recalling Model Number U125, VALITUDE 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 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 100258, 100259, 100263, 100270, 100285, 100287, 100292, 100298, 100301, 100302, 100307, 100310, 100315, 100323, 100331, 100333, 100339, 100342, 100343, 100348, 100349, 100350, 100357, 100358, 100359, 100360, 100362, 100366, 100367, 100371, 100372, 100375, 100378, 100386, 100390, 100392, 100394, 100396, 100397, 100401, 100402, 100403, 100406, 100409, 100412, 100413, 100418, 100419, 100420, 100423, 100429, 100430, 100432, 100435, 100438, 100448, 100452, 100453, 100455, 100456, 100458, 100462, 100466, 100467, 100472, 100473, 100475, 100476, 100480, 100481, 100482, 100485, 100486, 100489, 100492, 100493, 100495, 100496, 100497, 100498, 100499, 100500, 100502, 100505, 100510, 100514, 100518, 100526, 100529, 100532, 100533, 100536, 100537, 100539, 100540, 100541, 100544, 100546, 100548, 100549, 100552, 100560, 100566, 100570, 100572, 100573, 100575, 100576, 100578, 100582, 100583, 100585, 100591, 100593, 100598, 100603, 100605, 100612, 100614, 100618, 100625, 100626, 100632, 100635, 100636, 100640, 100642, 100643, 100645, 100646, 100647, 100648, 100650, 100653, 100657, 100658, 100661, 100666, 100671, 100672, 100674, 100676, 100679, 100683, 100684, 100687, 100690, 100692, 100693, 100697, 100699, 100700,…
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-0101-2026 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.