Model Number U128, VALITUDE CRT-P EL MRI
type: Dataset
description: FDA recall Z-0102-2026 — Boston Scientific Corporation is recalling Model Number U128, VALITUDE 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 U128, VALITUDE CRT-P EL MRI
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0102-2026: Boston Scientific Corporation is recalling Model Number U128, VALITUDE CRT-P EL MRI
claims: FDA classified recall Z-0102-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0102-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0102-2026
      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 00802526559402, Serial numbers: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363, 100364, 100369, 100372, 100373, 100376, 100379, 100381, 100386, 100391, 100392, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100410, 100411, 100414, 100417, 100420, 100433, 100435, 100437, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100456, 100458, 100459, 100463, 100466, 100471, 100473, 100474, 100475, 100476, 100481, 100482, 100483, 100484, 100485, 100486, 100491, 100497, 100500, 100501, 100502, 100503, 100506, 100507, 100511, 100513, 100514, 100519, 100520, 100522, 100523, 100527, 100533, 100535, 100536, 100537, 100539, 100541, 100544, 100545, 100547, 100550, 100551, 100553, 100556, 100557, 100560, 100562, 100563, 100564, 100565, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100577, 100580, 100581, 100583, 100586, 100589, 100590, 100592, 100593, 100595, 100596, 100601, 100605, 100607, 100615, 100616, 100618, 100619, 100620, 100621, 100624, 100626, 100627, 100633, 100635, 100637, 100639, 100641, 100646, 100648, 100650, 100652, 100655, 100656, 100657, 100662, 100666, 100669, 100670, 100672, 100673, 100678, 100682, 100683, 100685, 100686, 100687, 100688, 100697, 100700, 100702, 100707, 100708, 100709, 100715, 100717, 100718, 100719, 100721, 100724, 100725, 100726, 100727, 100730, 100735, 100736, 100740, 100748, 100749, 100750, 100757, 100759, 100761, 100765, 100768, 100772, 100773, 100777, 100784, 100785, 100791, 100794, 100801, 100805, 100807, 100808, 100811, 100816, 100822, 100825, 100829, 100831, 100833, 100834, 100835, 100839, 100841, 100842, 100849, 100850, 100852, 100853, 100854, 100855, 100856, 100859, 100861, 100865, 100867, 100870, 100871, 100872, 100880, 100881, 100882, 100885, 100888, 100895, 100898, 100907, 100912, 100918, 100921, 100925, 100930, 100939, 100940, 100941, 100943, 100949, 100952, 100953, 100955, 100956, 100957, 100965, 100…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0102-2026: Boston Scientific Corporation is recalling Model Number U128, VALITUDE CRT-P EL MRI
type: Claim
text: The FDA logged enforcement record Z-0102-2026: Boston Scientific Corporation is voluntarily recalling Model Number U128, VALITUDE 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 00802526559402, Serial numbers: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363, 100364, 100369, 100372, 100373, 100376, 100379, 100381, 100386, 100391, 100392, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100410, 100411, 100414, 100417, 100420, 100433, 100435, 100437, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100456, 100458, 100459, 100463, 100466, 100471, 100473, 100474, 100475, 100476, 100481, 100482, 100483, 100484, 100485, 100486, 100491, 100497, 100500, 100501, 100502, 100503, 100506, 100507, 100511, 100513, 100514, 100519, 100520, 100522, 100523, 100527, 100533, 100535, 100536, 100537, 100539, 100541, 100544, 100545, 100547, 100550, 100551, 100553, 100556, 100557, 100560, 100562, 100563, 100564, 100565, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100577, 100580, 100581, 100583, 100586, 100589, 100590, 100592, 100593, 100595, 100596, 100601, 100605, 100607, 100615, 100616, 100618, 100619, 100620, 100621, 100624, 100626, 100627, 100633, 100635, 100637, 100639, 100641, 100646, 100648, 100650, 100652, 100655, 100656, 100657, 100662, 100666, 100669, 100670, 100672, 100673, 100678, 100682, 100683, 100685, 100686, 100687, 100688, 100697, 100700, 100702, 100707, 100…
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-0102-2026 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.