VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
type: Dataset
description: FDA recall Z-0827-2025 — Boston Scientific Corporation is recalling VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) (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: VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0827-2025: Boston Scientific Corporation is recalling VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
claims: FDA classified recall Z-0827-2025 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0827-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0827-2025
      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: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-12-12
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: U225 - UDI-DI: 00802526559433, 00802526577116, 00802526577048, 00802526578809, Serial Numbers: 100320 100321 100388 100543 100545 100712 100717 100720 100734 100747 100787 100800 100804 100806 100807 100810 100819 100827 100828 100832 100834 100835 100845 100849 100850 100851 100852 100853 100856 100858 100865 100874 100879 100880 100887 100888 100889 100890 100892 100894 100895 100900 100901 100902 100905 100906 100907 100908 100913 100915 100916 100917 100919 100921 100922 100923 100924 100926 100928 100929 100930 100931 100932 100933 100934 700015 700016 700035 700039 700040 700043 700044 700047 700048 700052 700056 700060 700063 700064 700067 700071 700072 700075 700077 700080 700082 700084 700085 700088 700089 700092 700094 700099 700100 700102 700103 700104 700105 700108 700109 700110 700115 700121 700125 700128 700132 700134 700145 700148 700153 700160 700165 700170 700180 700188 700189 700246 700249 700268 700271 700274 700278 700279 700281 700285 700288 700291 700292 700296 700297 700298 700301 700302 700303 700304 700305 700308 700309 700310 700311 700313 700314 700315 700323 700324 700327 700328 700329 700330 700331 700332 700333 700334 700336 700337 700338 700339 700341 700342 700343 700346 700348 700349 700350 700352 700353 700354 700355 700356 700357 700361 700362 700363 700364 700365 700367 700368 700370 700371 700372 700374 700375 700376 700377 700378 700379 700381 700382 700383 700384 700386 700387 700388 700391 700392 700393 700394 700396 700397 700398 700403 700405 700406 700407 700408 700409 700410 700411 700412 700414 700415 700416 700417 700418 700419 700420 700421 700422 700423 700424 700425 700427 700428 700429 700430 700431 700432 700434 700435 700437 700438 700439 700440 700441 700442 700443 700444 700445 700446 700447 700448 700449 700450 700451 700452 700453 700454 700455 700457 700458 700459 700461 700462 700463 700464 700465 700466 700467 700468 700469 700470 700471 700472 700473 700475 700476 700477 700478 700479 700480 700484 700491 7…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
      status: recorded

FDA recall Z-0827-2025: Boston Scientific Corporation is recalling VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
type: Claim
text: The FDA logged enforcement record Z-0827-2025: Boston Scientific Corporation is voluntarily recalling VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) — reason: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-12. Affected lots/codes: U225 - UDI-DI: 00802526559433, 00802526577116, 00802526577048, 00802526578809, Serial Numbers: 100320 100321 100388 100543 100545 100712 100717 100720 100734 100747 100787 100800 100804 100806 100807 100810 100819 100827 100828 100832 100834 100835 100845 100849 100850 100851 100852 100853 100856 100858 100865 100874 100879 100880 100887 100888 100889 100890 100892 100894 100895 100900 100901 100902 100905 100906 100907 100908 100913 100915 100916 100917 100919 100921 100922 100923 100924 100926 100928 100929 100930 100931 100932 100933 100934 700015 700016 700035 700039 700040 700043 700044 700047 700048 700052 700056 700060 700063 700064 700067 700071 700072 700075 700077 700080 700082 700084 700085 700088 700089 700092 700094 700099 700100 700102 700103 700104 700105 700108 700109 700110 700115 700121 700125 700128 700132 700134 700145 700148 700153 700160 700165 700170 700180 700188 700189 700246 700249 700268 700271 700274 700278 700279 700281 700285 700288 700291 700292 700296 700297 700298 700301 700302 700303 700304 700305 700308 700309 700310 700311 700313 700314 700315 700323 700324 700327 700328 700329 700330 700331 700332 700333 700334 700336 700337 700338 700339 700341 700342 700343 700346 700348 700349 700350 700352 700353 700354 700355 700356 700357 700361 700362 700363 700364 700365 700367 700368 700370 700371 700372 700374 700375 700376 700377 700378 700379 700381 700382 700383 700384 700386 700387 700388 700391 70039…
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-0827-2025 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.